Label: M-DRYL- diphenhydramine hydrochloride liquid
- NDC Code(s): 58657-528-04, 58657-528-16
- Packager: Method Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated November 16, 2022
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SPL UNCLASSIFIED SECTION
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
- Sneezing
- Active ingredient
- Purpose
- Uses
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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
- to make a child sleepy
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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 - take every 4 to 6 hours
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
M-DRYL
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58657-528 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58657-528-04 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2019 2 NDC:58657-528-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/01/2019 Labeler - Method Pharmaceuticals, LLC (060216698)