ALLERGY TIME- chlorpheniramine maleate tablet

Allergy Time by

Drug Labeling and Warnings

Allergy Time by is a Otc medication manufactured, distributed, or labeled by Time Cap Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg

PURPOSE

Purpose: Antihistamine

INDICATIONS & USAGE

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

WARNINGS

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

ASK DOCTOR/PHARMACIST

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

WHEN USING

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/08/2011

Labeler - Time Cap Labs Inc (037052099)

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