FDA Label for Diphenhydramine Hcl
View Indications, Usage & Precautions
Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Invahealth Inc. 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
Otc - When Using
Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
taking sedatives or tranquilizers
Otc - Pregnancy Or Breast Feeding
ask a health professional before use.
Otc - 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)
Otc - Questions
609-642-6380
Inactive Ingredient
Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 3, magnesium stearate, microcrystalline cellulose, polyethylene glycol, hydroxy propyl methyl cellulose talc, titanium dioxide
Dosage & Administration
take every 4 to 6 hours do not take more than 6 doses in 24 hours
adults & children 12 years & over 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use this product in children under 6 years of age
Warnings
Do not use
to make a child sleepy
with any other product containing diphenhydramine, even one used on skin
Indications & Usage
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
temporarily relieves these symptoms due to the common cold:
runny nose
sneezing
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