COLD AND COUGH- acetaminophen and dextromethorphan hydrobromide liquid 
Walgreen Company

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.

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Walgreen Co. Cold & Cough Drug Facts

Active ingredients (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Purpose

Pain reliever

Cough suppressant

Uses

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoons (3,000 mg acetaminophen) in 24 hours. 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

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

•
liver disease
•
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

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)
•
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

adults & children 12 years & over
•
take 2 tablespoons (TBSP) in dose cup provided every 6 hours
•
do not take more than 6 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 25 mg and sodium 8 mg
•
store between 20-25°C (68-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue #1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose

Questions or comments?

1-800-719-9260

Principal Display Panel

DAYTIME

NON-DROWSY

Cold & Cough

Acetaminophen / Sore Throat / Body Aches / Headache

Dextromethorphan HBr / Coughing

Pain reliever & cough suppressant

COOL ICE® INSTANT COOLING SENSATION

8 FL OZ (237 mL) LIQUID

Compare to Tylenol® Cold & Cough active ingredients

Walgreens Cold & Cough 1.jpg
Walgreens Cold & Cough 2.jpg
COLD AND COUGH 
acetaminophen, dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0698
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
FD&C BLUE NO. 1 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
Product Characteristics
ColorBLUE (clear) Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0698-34237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/09/2011
Labeler - Walgreen Company (008965063)

Revised: 3/2014
Document Id: f605a9a5-81c5-4d82-847f-ff3c3af60f01
Set id: 03010339-d09c-4c96-a2f8-1d9733214cee
Version: 2
Effective Time: 20140319
 
Walgreen Company