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NDC 36800-0504-03 Severe Cold PE 325; 12.5; 5 mg/1; mg/1; mg/1 Details

Severe Cold PE 325; 12.5; 5 mg/1; mg/1; mg/1

Severe Cold PE is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by TopCare. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 36800-0504-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine 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: 36800-0504-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

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: 36800-0504-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	36800-0504
Product ID	36800-504_d0d6c989-213e-0d0c-e053-2995a90ac133
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Severe Cold PE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	325; 12.5; 5
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	TopCare
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2022-12-31

Package

NDC 36800-0504-03 (36800050403)

Pricing Information	N/A
NDC Package Code	36800-504-03
Billing NDC	36800050403
Package	2 BLISTER PACK in 1 CARTON (36800-504-03) / 12 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date	2013-07-01
NDC Exclude Flag	N