Otc - Active Ingredient
Active Ingredient (in each 15 mL = 1 tablespoon):
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Kingston Pharma Llc for the product Daytime Cough (NDC 71027-040). 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 10 mg
Phenylephrine HCl 5 mg
Purpose: Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
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.
Overdose Warning: In case of accidental overdose, seek professional assistance or contact a Poison control center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
If pregnant or breast-feeding, ask a health professional before use.
Directions:
Other information
Inactive ingredients: Butylated hydroxyanisole, Edetate disodium, FD&C yellow 6, flavor, Glycerin, Menthol, Monobasic sodium phosphate, Polyethylene glycol, Propylene glycol, Saccharin sodium, Sucrose, Xanthan gum and Purified Water.
(packs: 4oz) Kingston NDC# 71027-040-06
Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662
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