OTC Medication Information: Severe Cold

SEVERE COLD- acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet, film coated
United Natural Foods, Inc. dba UNFI

Active ingredients (in each caplet)

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

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms:
    • sore throat
    • cough
    • nasal congestion
    • headache
    • minor aches and pains
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • 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

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

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.

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-855-423-2630

Principal Display Panel

EQUAL INE®

NDC 41163-053-08

multi-symptom
severe cold
acetaminophen
(pain reliever/fever reducer)
dextromethorphan HBr
(cough suppressant)
guaifenesin
(expectorant)
phenylephrine HCl
(nasal decongestant)

relieves:
• headache & fever
• sore throat
• nasal congestion
• cough & mucus

24 caplets actual size

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

50844 REV0922D50308

DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908 USA
100% Quality Guaranteed
855-423-2630

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Equaline 44-503
(click image for full-size original)

Equaline 44-503

SEVERE COLD acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-053
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:41163-053-08 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (41163-053-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 01/27/2023
Labeler — United Natural Foods, Inc. dba UNFI (943556183)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (41163-053), pack (41163-053)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (41163-053)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (41163-053)

Revised: 01/2024 United Natural Foods, Inc. dba UNFI

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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