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NDC 49483-0242-00 Allergy Time 4 mg/1 Details

Allergy Time 4 mg/1

Allergy Time is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Time Cap Labs 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: 49483-0242-00
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

Product Information

NDC	49483-0242
Product ID	49483-242_7d393588-61e4-0606-e053-2a91aa0a83b2
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	Allergy Time
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	Time Cap Labs 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 49483-0242-00 (49483024200)

Pricing Information	N/A
NDC Package Code	49483-242-00
Billing NDC	49483024200
Package	100000 TABLET in 1 CARTON (49483-242-00)
Marketing Start Date	2018-12-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 588c424a-8dd6-417e-8f76-2ce0cc2b0c12 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg

SPL UNCLASSIFIED SECTION

Purpose: Antihistamine

SPL UNCLASSIFIED SECTION

Uses: temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itching of the nose or throat, itch, watery eyes

SPL UNCLASSIFIED SECTION

Warnings Ask a doctor before use if you have: glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty urinating due to an enlarged prostate gland

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

When using this product: excitability may occur, especially in children; drowsiness may occur; avoid alcoholic beverages; alcohol, sedatives and tranquilizers may increase drowsiness; use caution when driving a motor vehicle operating machinery

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding ask a health professional before use.

SPL UNCLASSIFIED SECTION

Directions Adults and children 12 years and over - 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours Children 6 to under 12 years of age - 1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours Children under 6 years of age - do not use

SPL UNCLASSIFIED SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALLERGY TIME

chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49483-242
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	yellow	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	TCL242
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49483-242-00	100000 in 1 CARTON; Type 0: Not a Combination Product	12/17/2018
2	NDC:49483-242-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2018
3	NDC:49483-242-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2018
4	NDC:49483-242-24	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/17/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/08/2011

Labeler - Time Cap Labs Inc (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
Time Cap Labs Inc		037052099	manufacture(49483-242)

Revised: 12/2018

Document Id: 7d393588-61e4-0606-e053-2a91aa0a83b2

Set id: 588c424a-8dd6-417e-8f76-2ce0cc2b0c12

Version: 2

Effective Time: 20181217

Search by Drug Name or NDC

NDC 49483-0242-00 Allergy Time 4 mg/1 Details

Allergy Time 4 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49483-0242-00 (49483024200)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 588c424a-8dd6-417e-8f76-2ce0cc2b0c12 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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