Active Ingredient (In Each Tablet)
Chlorpheniramine maleate 4 mg
Allergy Relief Tablet
FDA Label NDC 71335-2812
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Allergy Relief (NDC 71335-2812). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- runny nose
- itchy, watery eyes
- itching of the nose or throat
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
- difficulty in urination due to enlargement of the 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
- use caution when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
- 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
- take every 4 to 6 hours, or as directed by a doctor
| adults and children 12 years and over | 1 tablet. Do not exceed 6 tablets in 24 hours. |
| children 6 to under 12 years | 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. |
| children under 6 years | do not use |
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from excessive moisture
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose
Questions Or Comments?
Call 833-358-6431
Monday to Friday 9:00am to 7:00pm EST
How Supplied
Chlorpheniramine maleate 4 mg: color yellow, score 2, shape round and the imprint code 44;194.
NDC: 71335-2812-1: 30 Tablets in a BOTTLE, PLASTIC
NDC: 71335-2812-2: 60 Tablets in a BOTTLE, PLASTIC
NDC: 71335-2812-3: 100 Tablets in a BOTTLE, PLASTIC
NDC: 71335-2812-4: 120 Tablets in a BOTTLE, PLASTIC
NDC: 71335-2812-5: 40 Tablets in a BOTTLE, PLASTIC
NDC: 71335-2812-6: 24 Tablets in a BOTTLE, PLASTIC
Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
protect from excessive moisture.
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
Package Label.Principal Display Panel
Chlorpheniramine Maleate 4 mg Tablet
Label (Lbl713352812)
* Please review the disclaimer below.
