FDA Label for Allergy Relief
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - DO NOT USE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. 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
Active ingredient (in each caplet)
Diphenhydramine HCl 25 mg
Otc - Purpose
Purpose
Antihistamine
Indications & Usage
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:
Warnings
Warnings
Otc - Ask Doctor
Ask a doctor before use if you have
- glaucoma
- trouble urinating due to enlarged prostrate gland
- a breathing problem such as emphysema or chronic bronchitis
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/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 of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Dosage & Administration
Directions
- Take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times 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
Other Safety Information
Other information
- each caplet contains: calcium 25 mg
- protect from light
- Store between 20-25°C (68-77° 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
Package Label.Principal Display Panel
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