OTC Medication Information: M-Dryl

M-DRYL- diphenhydramine hydrochloride liquid
Bryant Ranch Prepack

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

M- Dryl

Diphenhydramine Hydrochloride Oral Solution

Antihistamine

Cherry Flavor

RELIEVES

  • Sneezing
  • Itchy, Watery Eyes
  • Runny Nose
  • Itchy Throat due to Allergies

DO NOT USE IF TAMPER EVIDENT SEAL

UNDER CAP IS BROKEN OR MISSING

Alcohol Free

Each 5 mL (1 teaspoonful) contains:

Diphenhydramine HCl ……………. 12.5 mg

Drug Facts

Active ingredient

(in each 5 mL = 1 tsp)

Diphenhydramine HCl …………………………………………….. 12.5 mg

Purpose

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

Warnings

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

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

If pregnant or breast-feeding ,

ask a health professional before use.

Keep out of 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
  • use an accurate measuring device to administer this Medication
children under 2 years do not use do not use
children 2 to 5 years ask a doctor
children 6 years to under 12 years 5 mL (1 tsp) to 10 mL (2 tsp); not more than 60 mL (12 tsp) in 24 hours
adults and children 12 years and over 10 mL (2 tsp) to 20 mL (4 tsp); not more than 120 mL (24 tsp) in 24 hours

Other information

  • each tsp contains: sodium 5 mg
  • store at 15° to 30°C (59° to 86°F)

protect from freezing

Inactive ingredients

Cherry Flavor, Citric Acid Anhydrous, FD&C red No. 40, Glycerin, Masking Agent, Propylene Glycol, Purified water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution.

Questions?

Serious side effects associated with use of this product may be reported to this number. Call 1-877-250-3427 Mon. — Fri. (8 a.m. to 5 p.m. CST).

HOW SUPPLIED

NDC: 63629-1160-1 473 mL in a BOTTLE

M-Dryl Oral Liquid 12.5 MG/5ML

Label
(click image for full-size original)
M-DRYL
diphenhydramine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63629-1160(NDC:58657-528)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE, UNSPECIFIED FORM
SACCHARIN SODIUM
SORBITOL
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-1160-1 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 08/01/2019
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-1160), RELABEL (63629-1160)

Revised: 10/2020 Bryant Ranch Prepack

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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