FDA Label for Walgreens Childrens
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 10 ML)
- PURPOSE
- USES
- DO NOT US
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Walgreens Childrens Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 10 Ml)
Chlorpheniramine maleate, USP 2 mg
Dextromethorphan HBr USP 15 mg
Purpose
Antihistamine
Cough suppressant
Uses
▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:▪ runny nose▪ sneezing▪ itching of the nose or throat▪ itchy, watery eyes
Do Not Us
▪ to sedate a child or to make a child sleepy▪ 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
▪ trouble urinating due to an enlarges prostate gland▪ glaucoma▪ a cough that occurs with too much phlegm (mucus)▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
▪ do not use more than directed.▪ marked drowsiness may occur▪ avoid alcoholic drinks▪ alcohol, sedatives and tranquilizers may increase drowsiness▪ be careful when driving a motor vehicle or operating machinery▪ excitability may occur, especially in children
Stop Use And Ask A Doctor If
▪ cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. 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 (1-800-222-1222) right away
Directions
▪ measure only with dosing cup provided.▪ keep dosing cup with product▪ mL= milliliter▪ do not take more than 4 doses in any 24-hour period
age | dose |
Children under 6 years | Do not use |
Children 6 to under 12 years | 10 mL every 6 hours |
Adults and children 12 years and older | 20 mL every 6 hours |
Other Information
▪ each 10 mL contains: sodium 3 mg• store at room temperature. Do not refrigerate• contain low sodium• do not use if printed seal under cap is torn or missing
Inactive Ingredients
anhydrous citric acid, FD&C Red # 40, flavor, potassium sorbate, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose
Questions Or Comments?
1-866-467-2748
Principal Display Panel
Compare to the Children's Robitussin® Nighttime Cough DM active ingredients††
NDC# 0363-7560-04
Children's
Nighttime Cough
Wal-Tussin® DM
CHLORPHENIRAMINE MALEATE, USP 2 mg/10 mL
ANTIHISTAMINE
DEXTROMETHORPHAN HBr, USP 15 mg/15 mL
COUGH SUPPRESSANT
NIGHTTIME
Relieves cough & runny nose
6 YEARS & OLDER
Fruit Punch Flavor
NATURALLY AND ARTIFICIALLY FLAVORED
Dosage cup included
2-4 FL OZ (118 mL) BOTTLES TOTAL – 8 FL OZ (236 mL)
Walgreens PHARMACIST RECOMMENDED†
Health expertise you rely on, quality you trust
†Walgreens Pharmacists Survey
*This product is not manufactured or distributed by Pfizer, owner of the registered trademarks Children’s Robitussin®
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
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