M-dryl

M-dryl
SPL v1
SPL
SPL Set ID 42a0e577-a1b6-2c16-e063-6294a90af8e3
Route
ORAL
Published
Effective Date 2019-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-01

Description

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


Medication Information

Description

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

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
Section 42229-5

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

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
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
Questions?

Serious side effects associated with use of this product may be reported to this number.

For any adverse reactions contact FDA www.FDA.gov or Call: (888) 463-6332

Active Ingredient

(in each 5 mL = 1 tsp)

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

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.

Principal Display Panel





M-Dryl



Diphenhydramine Hydrochloride



Oral Solution



Antihistamine

Cherry Flavor

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. 

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.


Structured Label Content

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
Section 42229-5 (42229-5)

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

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
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
Questions?

Serious side effects associated with use of this product may be reported to this number.

For any adverse reactions contact FDA www.FDA.gov or Call: (888) 463-6332

Active Ingredient (Active ingredient)

(in each 5 mL = 1 tsp)

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

Other Information (Other information)
  • each tsp contains:sodium 5 mg

  • store at 15° to 30°C (59° to 86°F) 

protect from freezing

Inactive Ingredients (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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)





M-Dryl



Diphenhydramine Hydrochloride



Oral Solution



Antihistamine

Cherry Flavor

When Using This Product (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 (If pregnant or breast-feeding)

ask a health professional before use.

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. 

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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