FDA Label for Allergy Relief
View Indications, Usage & Precautions
- 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 OF BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Top Care (topco Associates 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.
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
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- runny nose
- sneezing
temporarily relieves these symptoms of 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
a breathing problem such as emphysema or chronic bronchitis
glaucoma
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
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when operating machinery or driving a motor vehicle
- excitability may occur, especially in children
If Pregnant Of 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. (1-800-222-1222)
Directions
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
adults and children 12 years and over | take 1 to 2 tablets |
children 6 to under 12 years | take 1 tablet |
children under 6 years | do not use |
Other Information
- each tablet contains: calcium 25mg
- store between 20-25°C (68-77°F)
- protect from light and moisture
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, polyvinyl alcohol*, *purified water, *talc, and titanium dioxide
* Contains one or more of these ingredients
Questions Or Comments?
Call toll free 1-888-423-0139
Principal Display Panel
COMPARE TO BENADRYL® ALLERGY ACTIVE INGREDIENT**
Allergy Relief
DIPHENHYDRAMINE HCI 25 mg - ANTIHISTAMINE
RELIEF OF:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
TABLETS
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY TOPCO ASSOCIATED LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO PLVA0218
Product Label
* Please review the disclaimer below.