FDA Label for Allergy
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Kroger Company. 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.
Otc - Active Ingredient
Diphenhydramine HCl 25 mg
Otc - Purpose
Antihistamine
Indications & Usage
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itchy nose or throat
- runny nose
- sneezing
temporarily relieves these symptoms due to the common cold:
Warnings
Warnings
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
- 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
Otc - When Using
When using this product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
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 ot children. In case of overdose, get medical help or contact a Poison Control Center right away(l-800-222-1222).
Dosage & Administration
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 caplets
children 6 to under 12 years of age 1 caplet
children under 6 years of age do not use this product in children under 6 years of age
Other Information
Other information
- each caplet contains: calcium 25 mg
- protect from light
- store at 25°C (77°F) excursions permitted 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredient
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide
Otc - Questions
Questions or comments?
1-800-632-6900
Package Label.Principal Display Panel
Allergy 400ct Carton
Allergy 400ct Label
Allergy 100ct Carton
Allergy 100ct label
Allergy 24ct Carton
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