Dimetane Capsule, Liquid Filled
FDA Label NDC 57237-367

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Dimetane (NDC 57237-367). 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 ingredient (in each softgel), purpose, uses, 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

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 25 mg & 50 mg

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

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

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

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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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 softgel
     children under 12 years                                         do not use 

Other Information

  • Store between 20-25°C (68-77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) 
  • Protect from moisture and light.
  • Tamper Evident: do not use if foil seal under cap is broken or missing.

Inactive Ingredients

25mg:- Gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

50mg:- FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol sorbitan solution

Questions Or Comments

Call 1-877-474-7464

†This product is neither manufactured nor distributed by the owner of the registered trademark Benadryl® and Liqui-Gels®

DIMETANE TM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: 10/UA/2016

* Please review the disclaimer below.