FDA Label for Only For Allergy
View Indications, Usage & Precautions
Only For Allergy Product Label
The following document was submitted to the FDA by the labeler of this product O4 Global Trading Usa, 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.
Drug Facts
Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25mg
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
• temporarily relieves these symptoms due to the common cold:
• runny nose
• sneezing
Warnings:
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 driving a motor vehicle or operating machinery
• excitability may occur, especially in children.
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, or as directed by doctor
• do not take more than 6 doses in 24 hours
| adults and children 12 years and over | • take 1 to 2 caplets |
| children 6 to under 12 years | • take 1 caplet |
| children under 6 years | • do not use |
Other Information:
• store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F).
• avoid excessive heat and light.
• store in dry place.
Inactive Ingredients:
croscarmellose sodium, dicalcium phosphate, D&C red No.27 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
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Packaging
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