Allergy time tablet

Otc - purpose section

Purpose: Antihistamine




Indications & usage 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

Warnings 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

Otc - ask doctor/pharmacist section

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

Otc - when using 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


Otc - pregnancy or breast feeding section

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

Dosage & administration 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

Otc - keep out of reach of children section

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

Inactive ingredient section

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

Ingredients and appearance - Product information

Allergy time tablet- Chlorpheniramine maleate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 52125-922
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Chlorpheniramine maleate ( UNII: V1Q0O9OJ9Z)( Chlorpheniramine - UNII: 3U6IO1965U ) 4 mgin 1

Inactive Ingredients

Ingredient Name Code
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
Shape ROUND Imprint Code TCL242
Size 8 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 52125-922-02 30 in 1 BLISTER PACK 2014/04/29

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA 2014/04/29

Labeler - REMEDYREPACK INC.( 829572556)

Package label.principal display panel

DRUG: Allergy Time

GENERIC: Chlorpheniramine Maleate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-922-02

COLOR: yellow

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: TCL242

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • chlorpheniramine maleate 4mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • CELLULOSE, MICROCRYSTALLINE
  • MAGNESIUM STEARATE
  • D&C YELLOW NO. 10
  • CROSCARMELLOSE SODIUM
  • SILICON DIOXIDE
  • STEARIC ACID