FDA Label for Nighttime Childrens Multi Symptoms Cold And Cough Multi-symptom Relief
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 236 ML BOTTLE LABEL
Nighttime Childrens Multi Symptoms Cold And Cough Multi-symptom Relief Product Label
The following document was submitted to the FDA by the labeler of this product Wal-mart Stores,inc.. 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.
Other
Drug Facts
Otc - Purpose
| Active ingredients (in each 15 mL) | Purpose |
|---|---|
Chlorpheniramine maleate 2 mg | Antihistamine |
Dextromethorphan HBr 15 mg | Cough suppressant |
Uses
temporarily relieves cold symptoms:
▪ cough due to minor throat & bronchial irritation▪ sneezing▪ runny nose
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.▪ to make a child sleep
Ask A Doctor Before Use If You Have
▪ glaucoma▪ 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▪ trouble urinating due to enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When Using This Product
▪ excitability may occur, especially in children▪ marked drowsiness may occur▪ avoid alcoholic drinks▪ be careful when driving a motor vehicle or operating machinery▪ alcohol, sedatives, & tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
• cough persists more than 1 week, tends to recur or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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 at 1-800-222-1222.
Directions
• take only as directed• do not exceed 4 doses per 24 hrs.• only use the dose cup provided
adults & children 12 yrs & over | 30 mL every 6 hrs. |
children 6 to under 12 yrs | 15 mL every 6 hrs. |
children 4 to under 6 yrs | do not use unless directed by a doctor |
children under 4 yrs | do not use |
Other Information
• each tablespoon contains:potassium 5 mg sodium 5 mg• store at room temperature
Inactive Ingredients
Anhydrous citric acid, FD&C Red No. 40, flavor, potassium citrate, potassium sorbate, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose
Questions Or Comments?
1-866-467-2748
Principal Display Panel - 236 Ml Bottle Label
Compare to the active ingredients in Children’s Vicks Nyquil™*
NDC 49035-545-08
Nighttime Children’s Multi-Symptoms
Cold & Cough
Chlorpheniramine maleate 2 mg,
Dextromethorphan HBr 15 mg
• Sneezing• Runny Nose• Cough
Sugar Free, Aspirin Free
Natural Cherry Flavor
Free of Alcohol & Acetaminophen
8 FL OZ (236 ml)
Distributed by:
Mae in the USA
With domestic and imported ingredients Factory Certified
TAMPER EVIDENT: Do not use if printed shrink band is missing or broken.
*This product is manufactured or distributed by Procter & Gamble, the distributor of Children’s Vicks® Nyquil™
* Please review the disclaimer below.