Siladryl Allergy Medicine
FDA Label NDC 21695-689

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Siladryl Allergy Medicine (NDC 21695-689). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient: Diphenhydramine HCl 12.5 mg (in each 5 mL*)

* 5 mL = 1 teaspoonful

Otc - Purpose

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 common cold:
      • runny nose
      • sneezing

Warnings

Do not use with any other product containing diphenhydramine, including one applied topically.

Otc - Ask Doctor

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
  • a sodium restricted diet

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Otc - When Using

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.

Directions

  • repeat dose every 4 to 6 hours
  • do not take more than 6 doses in any 24-hour period
    • adults and children 12 years and over
    		2 to 4 teaspoonfuls
    children 6 to under 12 years
    		1 to 2 teaspoonfuls
    children under 6 years
    		DO NOT USE

    Other information

    Store at room temperature 20°-25°C (68°-77°F).

Inactive Ingredients

citric acid, D&C red no. 33, FD&C red no. 40, black cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol, water.

Other

Questions

888-974-5279

† This product is not manufactured or distributed by Warner-Lambert Consumer Healthcare, owner of the registered trademark Benadryl®.

Manufactured by:
Silarx Pharmaceuticals, Inc.
19 West Street
Spring Valley, NY 10977
USA

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Principal Display Panel

Diphenhydramine 12.5mg/5ml (717c622c 570e 47d4 Be73 041a88e8ebf8 01)

Diphenhydramine 12.5mg/5ml (717c622c 570e 47d4 Be73 041a88e8ebf8 01)

* Please review the disclaimer below.