Search by Drug Name or NDC

NDC 70518-2961-00 Allergy 4 mg/1 Details

Allergy 4 mg/1

Allergy is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK 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: 70518-2961-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Chlorpheniramine

Product Information

NDC	70518-2961
Product ID	70518-2961_d7abbac1-124d-5be0-e053-2995a90a5aed
Associated GPIs	41100020150310
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	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	REMEDYREPACK 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	2023-12-31

Package

Package Images

NDC 70518-2961-00 (70518296100)

Pricing Information	N/A
NDC Package Code	70518-2961-0
Billing NDC	70518296100
Package	30 TABLET in 1 BLISTER PACK (70518-2961-0)
Marketing Start Date	2020-12-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0074d2d3-c0c5-4183-98d1-00b0c2152410 Details

Active ingredient (in each tablet)

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Uses

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

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Warnings

Do not use

to make a child sleepy.

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
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 (1-800-222-1222) right away.

Directions

take every 4 to 6 hours, or as directed by a doctor

adults and children 12 years and over	1 tablet. Do not exceed 6 tablets in 24 hours.
children 6 to under 12 years	1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
children under 6 years	do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protect from excessive moisture
see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

Questions or comments?

(800) 616-2471

PRINCIPAL DISPLAY PANEL

DRUG: Allergy

GENERIC: Chlorpheniramine Maleate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2961-0

COLOR: yellow

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: 44;194

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

CHLORPHENIRAMINE MALEATE 4mg in 1

INACTIVE INGREDIENT(S):

STARCH, CORN
D&C YELLOW NO. 10 ALUMINUM LAKE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE

INGREDIENTS AND APPEARANCE

ALLERGY

chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2961(NDC:0904-0012)
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	yellow	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	44;194
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70518-2961-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/07/2020

Labeler - REMEDYREPACK INC. (829572556)

Revised: 2/2022

Document Id: d7abbac1-124d-5be0-e053-2995a90a5aed

Set id: 0074d2d3-c0c5-4183-98d1-00b0c2152410

Version: 3

Effective Time: 20220210