OTC Medication Information: Cold and Flu Severe, Daytime, Nighttime

COLD AND FLU SEVERE, DAYTIME, NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Rite Aid Corporation

Active ingredients (in each caplet) (Daytime Cold & Flu Severe)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Active ingredients (in each caplet) (Nighttime Cold & Flu Severe)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • headache
    • sore throat
    • nasal congestion
    • minor aches and pains
    • sinus congestion and pressure
    • sneezing and runny nose (Nighttime only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (Daytime only)
  • helps clear nasal passages
  • relieves cough to help you sleep
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • high blood pressure
  • liver disease
  • diabetes
  • thyroid disease
  • heart disease
  • glaucoma (Nighttime only)
  • cough that occurs with too much phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not take DAYTIME and NIGHTTIME products at the same time.

Directions

  • do not take more than directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole – do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information

  • each caplet contains: sodium 3 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients (Daytime only)

corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Inactive ingredients (Nighttime only)

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

NDC 11822-5034-8

Compare to the active ingredients inTylenol® COLD + FLU SEVERE Day & Tylenol® COLD + FLU SEVERE Night*

COLD & FLU SEVERE

DAYTIME

ACETAMINOPHEN DEXTROMETHORPHAN HBrGUAIFENESINPHENYLEPHRINE HCl

PAIN RELIEVER/FEVER REDUCERCOUGH SUPPRESSANT • EXPECTORANTNASAL DECONGESTANTFever, Headache, Sore Throat,Nasal Congestion, Cough,Mucus, Chest Congestion

ACTUAL SIZE

NIGHTTIME

ACETAMINOPHEN CHLORPHENIRAMINE MALEATEDEXTROMETHORPHAN HBrPHENYLEPHRINE HCl

PAIN RELIEVER/FEVER REDUCERANTIHISTAMINE • COUGH SUPPRESSANTNASAL DECONGESTANTFever, Headache, Sore Throat,Runny Nose, Cough,Nasal Congestion

ACTUAL SIZE

PSEUDOEPHEDRINE FREE

16 DAYTIME
CAPLETS

8
NIGHTTIME
CAPLETS

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark
Tylenol® COLD + FLU SEVERE Day & Tylenol® COLD + FLU SEVERE Night.

SATISFACTION
GUARANTEE
If you’re not satisfied, we’ll
happily refund your money.

DISTRIBUTED BY: RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319 www.riteaid.com

50844 REV0922A50347308

PARENTS:
Learn about teen medicine abusewww.StopMedicineAbuse.org

Rite Aid 44-503A473C
(click image for full-size original)

Rite Aid 44-503A473C

COLD AND FLU SEVERE, DAYTIME, NIGHTTIME acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, guaifenesin, phenylephrine hcl kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-5034
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-5034-8 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 BLISTER PACK 16
Part 2 1 BLISTER PACK 8
Part 1 of 2
COLD AND FLU SEVERE DAYTIME acetaminophen, dextromethorphan hbr, guaifenesin phenylephrine hcl tablet, film coated
Product Information
Item Code (Source) NDC:11822-5347
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE, UNSPECIFIED
D&C YELLOW NO. 10 ALUMINUM LAKE
MAGNESIUM STEARATE
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
SUCRALOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape OVAL Size 19mm
Flavor MENTHOL Imprint Code 44;503
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-5347-9 8 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 06/30/2021
Part 2 of 2
COLD AND FLU SEVERE NIGHTTIME acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
Item Code (Source) NDC:11822-4753
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE, UNSPECIFIED
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C BLUE NO. 2 ALUMINUM LAKE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
SUCRALOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape OVAL Size 17mm
Flavor MENTHOL Imprint Code 44;473
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-4753-9 8 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 06/30/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 06/30/2021
Labeler — Rite Aid Corporation (014578892)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (11822-5034), pack (11822-5034)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (11822-5034)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (11822-5034)

Revised: 05/2023 Rite Aid Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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