Allergy
FDA Label NDC 29485-7007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mechanical Servants, Llc for the product Allergy (NDC 29485-7007). 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, otc - purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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

Active Ingredient

(in each caplet)

Diphenhydramine HCl (25 mg)

Otc - Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • sneezing
  • nasal congestion
  • runny nose
  • itchy, watery eyes

    • Temporarily relieves these symptoms due to common cold

    • runny nose
    • sneezing

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing Diphenhydramine, even one used on the skin

Ask A Doctor Before Use If You Have

  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking sedatives or tranquilizers

When Using This Product

  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

If Pregnant Or Breast-Feeding

ask a health professional before use

Keep Out Of The 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 a doctor
  • do not take more than 6 doses in 24 hours

    • adults and children 12 years and over         1 to 2 tablets

    children 6 to under 12 years                       1 tablet

    children under 6 years                               ask a doctor

Inactive Ingredients

colloidal silicon dioxide, corn starch, D & C red # 27 Aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions Or Comments?

Call 1-844-428-2538

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