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Topcare Cough and Sore Throat

Generic Name: acetaminophen and dextromethorphan hydrobromide
Dosage Form: oral liquid

For Professionals Indications Side Effects Dosage Interactions More...

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.

Topco Cough & Sore Throat Drug Facts

Active ingredient (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Purpose

Pain reliever

Cough suppressant

Uses

temporarily relieves:
minor aches and pains
headache
sore throat
cough due to a cold

Warnings

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

more than 4 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

Ask a doctor before use if you have

liver disease
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

pain or cough 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 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. (1-800-222-1222) 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 Liver warning)

adults and

children 12 years

and over

take 2 tablespoons (TBSP) in dose cup provided every 6 hours as needed
do not take more than 8 tablespoons in 24 hours

children under 12 years

do not use this adult product in children under 12 years of age

Other information

each tablespoon contains: potassium 20 mg and sodium 8 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose

Questions or comments?

1-888-423-0139

Principal Display Panel

Day Time

Non-Drowsy

Pain Relief

Cough & Sore Throat

See New Warnings Information

Pain Reliever – Cough Suppressant

Sore Throat, Body Aches/Headache – Acetaminophen

Coughing – Dextromethorphan HBr

Cool Ice®

Instant Cooling Sensation

Compare to Tylenol® Cough & Sore Throat active ingredients

Cough & Sore Throat Front Label

Cough & Sore Throat Back Label

Topcare Cough and Sore Throat
acetaminophen, dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-698
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg in 15 mL

Product Characteristics
Color	BLUE (clear)	Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:36800-698-34	237 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/10/2006

Labeler - Topco Associates LLC (006935977)

Revised: 08/2009

Topco Associates LLC

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