ALLERGY RELIEF 4 HOUR- chlorpheniramine maleate tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)
Available from:
Geri-Care Pharmaceutical Corp
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine 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
Authorization status:
OTC monograph final
Authorization number:
57896-974-01, 57896-974-10

ALLERGY RELIEF 4 HOUR- chlorpheniramine maleate tablet

Geri-Care Pharmaceutical Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HST 784 (974)

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

glaucoma

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged 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 right away.

Directions

do not exceed recommended dose

adults and children 12 years and over: take 1 tablet every 4 to 6 hours,

as needed, not more than 6 tablets in 24 hours or as directed by a doctor

children under 12: consult a doctor

Other information

Tamper Evident: Do not use if imprinted seal

under cap is missing or broken. store at 20-25°C (68-77°F);

excursions permitted between 15°-30°C (59°-86°F)

protect from moisture

Inactive ingredients

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

cellulose

Principal display panel

ALLERGY RELIEF 4 HOUR

chlorpheniramine maleate tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:578 9 6 -9 74

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE

MALEATE

4 mg

Geri-Care Pharmaceutical Corp

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

Product Characteristics

Color

ye llo w

S core

2 pieces

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

44;19 4

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:578 9 6 -9 74-0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 1/20 19

2

NDC:578 9 6 -9 74-10

10 0 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 7/0 1/20 19

Labeler -

Geri-Care Pharmaceutical Corp (611196254)

Registrant -

Geri-Care Pharmaceutical Corp (611196254)

Revised: 9/2019

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