Active Ingredient
Diphenhydramine HCl 25 mg
Allergy Tablet
FDA Label NDC 69168-048
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Allergy (NDC 69168-048). 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 active ingredient, purpose, uses, warnings, ask a doctor if you have, ask a doctor or pharmacist before use if you, when using this product, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat and these symptoms associated with the common cold: sneezing runny nose
Warnings
Do not usewith any other products containing diphenhydramine, including one applied topically
Ask A Doctor If You Have
a breathing problem such as emphysema or chronic bronchitis, glaucoma or 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 beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when drivinga motor vehicle or operating machinery
excitability may occur, especially in children
If Pregnant Or Breast-Feeding
ask a health professional before use
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center immediately
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 older: 25 mg to 50 mg (1 to 2 caplets)
Children 6 to under 12 years of age (See ** symbol below): 12.5 mg** to 25 mg (1 caplet)
Children under 6 years of age: Consult a doctor
** A 12.5 mg dosage strength is not available in this package. (Do not attempt to break caplet)
Inactive Ingredients
croscarmellose sodium, D.&C. Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
* Please review the disclaimer below.
