OTC Medication Information: Allergy Relief 4 Hour

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.

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

Questions or comments?

1-800-540-3765

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ALLERGY RELIEF 4 HOUR
chlorpheniramine maleate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-974
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
ANHYDROUS LACTOSE
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 44;194
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57896-974-01 100 TABLET in 1 BOTTLE None
2 NDC:57896-974-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/01/2019
Labeler — Geri-Care Pharmaceutical Corp (611196254)
Registrant — Geri-Care Pharmaceutical Corp (611196254)

Revised: 11/2021 Geri-Care Pharmaceutical Corp

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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