FDA Label for Childrens Cough Mucus Relief
View Indications, Usage & Precautions
- DRUG FACTSACTIVE INGREDIENTS(IN EACH 5 ML TEASPOONFUL)
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- CHILDREN'S COUGH MUCUS RELIEF PRODUCT LABEL
Childrens Cough Mucus Relief Product Label
The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. 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.
Drug Factsactive Ingredients(In Each 5 Ml Teaspoonful)
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg
Purpose
Cough suppressant
Expectorant
Uses
- temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes
Warnings
Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask A Doctor Before Use If The Child Has
- cough that occurs with too much phlegm (mucus)
- persistant or chronic cough such as occurs with asthma
When Using This Product
- do not use more than directed
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistant headache.
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away
Directions
- do not take more than 6 doses in any 24-hour period
age dose
Children 6 years to 12 years 1 to 2 teaspoonfuls (tsps) every 4 hours
Children 4 years to under 6 years 1/2 to 1 teaspoonful (tsps) every 4 hours
Children under 4 years do not use
Other Information
- each teaspoonful contains sodium 3 mg
- store between20-25°C (68-77°F)
- do not refrigerate
- dosing cup provided
- Keep carton for full direction for use
Inactive Ingredients
anhydrous citric acid, dextrose, D&C red #33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944
Children's Cough Mucus Relief Product Label
DISCOUNT
drug
mart
FOOD FAIR
DO NOT USE IF PRINTED SEAL, UNDER CAP IS TORN OR MISSING
COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S MUCINEX® COUGH*
Children's Cough Mucus Relief
Cough Suppressent
Expectorant
Dextromethorphan HBr 5 mg
Guaifensin 100 mg
Relieves Chest Congestion
Thins & Loosens Mucus
Alcohol free
for ages 4 to 12
CHERRY FLAVOR
4 FL OX (118 ml)
* this product is not manufactured or distributed by Reckitt Benckiser Inc., the distributer of Childrens Mucinex® Cough.
SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256
BX-052
* Please review the disclaimer below.