FDA Label for Allergy Relief
View Indications, Usage & Precautions
Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceutical Llc. 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
Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 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
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
Otc - Do Not Use
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
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. In case of overdose, get medical help or contact a Poison Control Center right away.
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 tablets |
children 6 to under 12 years of age | 1 tablet |
children under 6 years of age | do not use this product in children under 6 years of age |
Other Information
- store at controlled room temperature 15°-30° C (59°-86° F)
- protect from moisture and light
- see end flap for expiration date and lot number
- each tablet contains calcium 24 mg
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C red # 27 Al lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
Questions Or Comments?
1-888-333-9792
Principal Display Panel
COMPARE TO ACTIVE INGREDIENT OF
BENADRYL ® ALLERGY ULTRATAB ®*
Allergy
Diphenhydramine HCl 25 mg
Antihistamine
Sneezing, Runny Nose, Itchy Throat,
Itchy, Watery Eyes
Actual Size
36 tablets
* Please review the disclaimer below.