FDA Label for Chlorpheniramine Maleate 4 Mg
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- WARNINGS
- OTC - ASK DOCTOR/PHARMACIST
- GENERAL PRECAUTIONS
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- USES
- 16 HOW SUPPLIED
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Chlorpheniramine Maleate 4 Mg Product Label
The following document was submitted to the FDA by the labeler of this product Pd-rx Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
* Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Chlor-Trimeton®
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
Active Ingredient (In Each Tablet)
Chlorpheniramine maleate 4 mg
Purpose
Antihistamine
Warnings
Ask a doctor before use if you have
- glaucoma
- trouble urinating due to enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
General Precautions
When using this product
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Drug Facts continued on back of label
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800)222-1222.
Directions
adults and children 12 years and over | take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours |
children 6 years to under 12 years | take 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours |
children under 6 years | do not use |
Other Information
- each tablet contains: calsium 40 mg
- store at 15°-30°C (59°-86°F)
Inactive Ingredients
croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide
Questions Or Comments?
call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
Uses
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes
16 How Supplied
Chlorpheniramine MaleateTablets are available as follows:
4 mg: Yellow, round, scored tablet, debossed "heart”. Available in bottles of
24 tablets (NDC 72789-134-24)
Package Label.Principal Display Panel
Chlorpheniramine Maleate 4mg
ANTIHISTAMINE
* Please review the disclaimer below.