FDA Label for Adult Long Lasting-cough Relief
View Indications, Usage & Precautions
Adult Long Lasting-cough Relief Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium Llc. 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 Ingredient(S)
Dextromethorphan HBr, USP 15 mg
Purpose
Cough Suppressant
Use(S)
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Warnings
DO NOT USEYou 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
- a cough that occurs with too much phlegm (mucus)
- a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
Stop Use And Ask Doctor If
Cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Pregnancy/Breastfeeding
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.
Directions
- do not take more than 8 liquidgels in any 24-hour period
- adults and children 12 years and over: take 2 liquidgels every 6 to 8 hours, as needed
- children under 12 years: ask a doctor
Storage
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- store at 20°-25°C (68°-77°F)
- avoid excessive heat above 40°C (104°F)
- protect from light
- use by expiration date on package
Inactive Ingredients
Gelatin, Sorbitol, Sorbitan, FD&C Blue No.1, Water, Polyethylene Glycol 400, Povidone K-30, Glycerine, FD&C Red No. 40, Propylene Glycol.
Principal Display Panel
CARTON LABEL PDP
NDC # 68016-026-20
Adult Long-Lasting Cough Relief
DEXTROMETHORPHAN HBr, USP 15mg
COUGH SUPPRESSANT
Relieves cough for upto 8 hours
Non-drowsy
Non-Narcotic formula
20 softgels
BOTTLE LABEL PDP
NDC # 68016-026-20
Adult Long-Lasting Cough Relief
DEXTROMETHORPHAN HBr, USP 15mg
COUGH SUPPRESSANT
Relieves cough for about 8 hours
Non-Drowsy
Non-Narcotic Formula
20 Softgels
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