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NDC 54738-0103-03 Anti Allergy 4 mg/1 Details

Anti Allergy 4 mg/1

Anti Allergy is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Richmond Pharmaceuticals, Inc.. The primary component is CHLORPHENIRAMINE MALEATE.

MedlinePlus Drug Summary

Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine 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: 54738-0103-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

Product Information

NDC	54738-0103
Product ID	54738-103_5cc3ebfe-ce74-423d-e053-2a91aa0a4616
Associated GPIs	41100020150310
GCN Sequence Number	011640
GCN Sequence Number Description	chlorpheniramine maleate TABLET 4 MG ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	46512
HICL Sequence Number	004505
HICL Sequence Number Description	CHLORPHENIRAMINE MALEATE
Brand/Generic	Generic
Proprietary Name	Anti Allergy
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chlorpheniramine Maleate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	4
Active Ingredient Units	mg/1
Substance Name	CHLORPHENIRAMINE MALEATE
Labeler Name	Richmond Pharmaceuticals, Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 54738-0103-03 (54738010303)

Pricing Information	N/A
NDC Package Code	54738-103-03
Billing NDC	54738010303
Package	1000 TABLET in 1 BOTTLE (54738-103-03)
Marketing Start Date	2015-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 316db99f-5a13-48e0-9a6b-ab7a76fe4d28 Details

Active Ingredient

(in each tablet)

Chlorpheniramine Maleate 4 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies :

runny nose
itchy nose or throat
sneezing
itchy, watery eyes

Warnings

Ask a doctor before use if you have

glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives & tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating a machine
excitability may occur, especially in children
If pregnant or breast-feeding, 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[/S]

Adults & children 12 years and over	take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
children 6 years to under 12 years	take ½ tablet every 4 to 6 hours not more than 3 tablets in 24 hours
children under 6 years	do not use

Other Information

each tablet contains: calcium 40 mg
store between 15°-30°C (59°-86°F)
protect from moisture

Inactive Ingredients

croscarmellose sodium, D&C yellow #10 (al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch

Questions or Comments

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

PRINCIPAL DISPLAY PANEL

Chlorpheniramine Maleate 4 mg

Antihistamine

NDC: 54738-103-01 - 100 CPM tablets

NDC: 54738-103-03 - 1000 CPM tablets

NDC: 54738-103-14 - 24 CPM tablets

INGREDIENTS AND APPEARANCE

ANTI ALLERGY

chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-103
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	yellow (light yellow)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	AP;016
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54738-103-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015
2	NDC:54738-103-03	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015
3	NDC:54738-103-14	24 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/01/2015

Labeler - Richmond Pharmaceuticals, Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(54738-103)

Revised: 10/2017

Document Id: 5cc3ebfe-ce74-423d-e053-2a91aa0a4616

Set id: 316db99f-5a13-48e0-9a6b-ab7a76fe4d28

Version: 2

Effective Time: 20171030