OTC Medication Information: Severe Cold and Cough Daytime

SEVERE COLD AND COUGH DAYTIME- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
TOP CARE (Topco Associates LLC)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold
    • minor aches and pains
    • headache
    • nasal congestion
    • sore throat
    • cough due to minor throat and bronchial irritation
  • 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 inclide:

  • 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

  • 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.
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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, cough, or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with a 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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 (see overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL= milliliter
  • keep dosing cup with product
  • adults and children 12 years and over:
    • 30 mL every 4 hours
  • chlldren under 12 years of age: do not use

Other information

  • each 30 mL contains: sodium 16 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate

Principal Display Panel

COMPARE TO THERAFLU® DAYTIME SEVERE COLD & COUGH ACTIVE INGREDIENTS*

DAYTIME FOR ADULTS

Severe Cold & Cough Relief

ACETAMINOPHEN 650 mg PAIN RELIEVER • REVER REDUCER

DEXTROMETHORPHAN HBr 20 mg COUGH SUPPRESSANT

PHENYLEPHRINE HCI 10 mg NASAL DECONGESTANT

RELIEVES:

  • Cough
  • Nasal Congestion
  • Aches, Fever & Sore Throat

FOR AGES 12 +

CHERRY FLAVOR

Alcohol10%

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Theraflu® Daytime Severe Cold & Cough

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

QUESTIONS? 1888-423-0139

topcare@topco.com www.topcarebrand.com

Product Label

Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCI 10 mg

TOPCARE HEALTH Severe Cold & Cough Relief

SEVERE COLD AND COUGH DAYTIME
acetaminohpen, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-316
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ALCOHOL
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
MALTITOL
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-316-08 245 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 11/30/2015
Labeler — TOP CARE (Topco Associates LLC) (006935977)

Revised: 10/2019 TOP CARE (Topco Associates LLC)

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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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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