Active Ingredient (In Each Teaspoonful (5 Ml))
Diphenhydramine HCl 12.5 mg
Diphenhydramine Hcl Solution
FDA Label NDC 0904-6985
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Diphenhydramine Hcl (NDC 0904-6985). 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 active ingredient (in each teaspoonful (5 ml)), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- marked drowsiness may occur
- use caution when driving a motor vehicle or operating machinery
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
- do not take more than 6 doses in 24 hours
- mL = milliliter; FL OZ = fluid ounce
- find right dose on chart below
- take every 4 to 6 hours, or as directed by a doctor
| Age | Dose |
| adults and children 12 years and over | 2 - 4 teaspoonsful (25 mg to 50 mg) |
| children 6 to 11 years | 1 - 2 teaspoonsful (12.5 mg to 25 mg) |
| children 2 to 5 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
Other Information
- each teaspoonful (5 mL) contains: sodium 5 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose
Questions Or Comments?
(800) 616-2471
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MAJOR®
NDC 0904-6985-16
Diphenhydramine HCl
Oral Solution
Antihistamine
12.5 mg/5 mL
Institutional Dispensing only |
Cherry Flavored
Alcohol Free
16 FL OZ / 473 mL
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV1019A01521
Distributed by: MAJOR® PHARMACEUTICALS
Livonia, MI 48152
Rev. 03/21 M-17 Re-order No. 701181
Major 44-015 (Major 44 015 Dsp 1)
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