Otc - Active Ingredient
Active Ingredient (in each 15 mL = 1 tablespoon):
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Kingston Pharma Llc for the product Nitetime Cough (NDC 71027-041). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient (in each 15 mL = 1 tablespoon):
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Purpose:
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes
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:
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.
When using this product
Stop use and ask doctor if
These could be signs of a serious condition
Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison control center right away.
If pregnant or breast-feeding, ask a health professional before use.
Directions:
Other information
Inactive ingredients: Alcohol, Anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, High fructose corn syrup, Polyethylene glycol, Propylene glycol, Saccharin sodium, Sodium citrate and Purified Water.
(packs: 4oz, 6oz, 10oz & 12oz) Kingston NDC# 71027-041-06
Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662
* Please review the disclaimer below.