Only For Allergy
FDA Label NDC 73006-148
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by O4 Global Trading Usa, Llc for the product Only For Allergy (NDC 73006-148). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient (in each caplet), purpose, uses:, warnings:, otc - keep out of reach of children, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Questions Or Comments?
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Packaging
Image (73006 148 95 1)
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