Sohmed Allergy
FDA Label NDC 50405-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sohm Inc. for the product Sohmed Allergy (NDC 50405-004). 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 other, active ingredients (in each caplet), purpose, uses, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by : Sohm, Inc.
6920 Knott Ave., Suit A-C,
Buena Park, CA 90621

Active Ingredients (In Each Caplet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies :
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • temporarily relieves symptoms due to the common cold:
      • runny nose
      • sneezing

Otc - Do Not Use

Do not use 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

Otc - Ask Doctor/Pharmacist

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take every 4 to 6 hours
  • do not take more than 6 times in 24 hours
    • adults and children 12 years and over1 to 2 caplets
    children 6 to under 12 years1 caplet
    children under 6 yearsconsult a doctor

Other Information

  • Store between 20°-25°C (68°-77°F).
    Avoid high humidity. Protect from light
  • See end flap for expiration date and lot number

Inactive Ingredients

croscarmellose sodium, D&C Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide, May contain polysorbate.

Question Or Comments?

1 (856) 2863646

Principal Display Panel - 24 Caplet Bottle Carton

NDC XXXXXXXXXX

SohMed™
*Compare to the active ingredients in Benadryl® Allergy Ultratab®

Antihistamine

Allergy

Diphenhydramine HCl 25 mg

24 Caplets

• Runny Nose • Itchy, Watery Eyes
• Sneezing • Itchy throat

Principal Display Panel (24 Caplet Bottle Carton)

Principal Display Panel (24 Caplet Bottle Carton)

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