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NDC 50991-0723-16 Poly-Tussin AC 4; 10; 10 mg/5mL; mg/5mL; mg/5mL Details

Poly-Tussin AC 4; 10; 10 mg/5mL; mg/5mL; mg/5mL

Poly-Tussin AC is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Poly Pharmaceuticals, Inc.. The primary component is BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 50991-0723-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Brompheniramine

Codeine is used to relieve mild to moderate pain. It is also used, usually in combination with other medications, to reduce coughing. Codeine will help relieve symptoms but will not treat the cause of symptoms or speed recovery. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen (Capital and Codeine, Tylenol with Codeine), aspirin, carisoprodol, and promethazine and as an ingredient in many cough and cold medications. This monograph only includes information about the use of codeine. If you are taking a codeine combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.

Related Packages: 50991-0723-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Codeine

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 50991-0723-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	50991-0723
Product ID	50991-723_efbb79b0-5f44-7ada-e053-2995a90ae470
Associated GPIs	43995303110935
GCN Sequence Number	072562
GCN Sequence Number Description	brompheniramine/p-eph/codeine LIQUID 4-10-10/5 ORAL
HIC3	B3Q
HIC3 Description	OPIOID ANTITUSSIV-1ST GEN. ANTIHISTAMINE-DECONGEST
GCN	36828
HICL Sequence Number	035361
HICL Sequence Number Description	BROMPHENIRAMINE MALEATE/PHENYLEPHRINE HCL/CODEINE PHOSPHATE
Brand/Generic	Brand
Proprietary Name	Poly-Tussin AC
Proprietary Name Suffix	n/a
Non-Proprietary Name	Brompheniramine Maleate, Codeine Phosphate, Phenylephrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	4; 10; 10
Active Ingredient Units	mg/5mL; mg/5mL; mg/5mL
Substance Name	BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Poly Pharmaceuticals, Inc.
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	CV
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

NDC 50991-0723-16 (50991072316)

Pricing Information	N/A
NDC Package Code	50991-723-16
Billing NDC	50991072316
Package	473 mL in 1 BOTTLE (50991-723-16)
Marketing Start Date	2014-06-02
NDC Exclude Flag	N