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Drug Facts
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
Allergy Relief Antihistamine
FDA Label NDC 63868-474
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cdma Inc for the product Allergy Relief Antihistamine (NDC 63868-474). 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 other, active ingredient (in each softgel), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Diphenhydramine HCl 25mg
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
- runny nose
- sneezing
temporarily relieves these symptoms due to the common cold:
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- glaucoma
- trouble urinating due to an 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
When Using This Product
- marked drowsiness may occur
- 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
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
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours.
| adults and children 12 years of age and over | 1 to 2 softgel |
| children 6 to under 12 years | 1 softgel |
| children under 6 years of age | do not use this product |
Other Information
- store at room temperature between 20-25°C (68-77°F)
- avoid excessive heat, humidity and light
Inactive Ingredients
gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions Or Comments?
Call: 1-888-577-8033 Monday - Friday 9am-4:30pm EST
Principal Display Panel - 24 Softgel Blister Pack Carton
QC®
QUALITY
CHOICE
NDC 63868-474-24
*Compare to the active
Ingredient in BENADRYL®
Allergy LIQUI-GELS®
Dye-Free
Allergy Relief
Antihistamine
- Relieves sneezing
- Itchy, watery eyes
- Runny nose
- Itchy throat
Diphenhydramine HCl
25 mg
24 Softgels
Actual Size
Principal Display Panel (24 Softgel Blister Pack Carton)
* Please review the disclaimer below.
