Active Ingredient (In Each 5 Ml-Teaspoonful)
Diphenhydramine KCI 12.5mg
Diphenhydramine Oral Solution
FDA Label NDC 73564-814
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldama Pharmaceuticals, Inc for the product Diphenhydramine Oral Solution (NDC 73564-814). 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 5 ml-teaspoonful), purpose, uses, warnings, 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, 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 of hay fever or other upper respiratory allergies:
- runny nose
- itchy nose or throat
- sneezing
- itchy, watery eyes
- runny nose
- sneezing
Temporarily relieves these symptoms due to the common cold
Warnings
Do not use
with any other drug containing diphenhydramine, including one used on the skin.
to make a child sleepy
Do Not Use
- with any other drug containing diphenhydramine, including one used on the skin.
- to make a child sleepy
Ask A Doctor Before Use If You Have
- a breathing problem such as chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
- glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving motor vehicle or operating machinery
- avoid alcoholic drinks
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 hours, as needed, or as directed by a doctor
- Do not take more than 6 doses in 24 hours
- adults and children 12 years and over: 10 to 20 ml 2 to 4 teaspoonsful
- Children under 12 years: consult a doctor
Other Information
- TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing
- store at room temperature between 15-30°C (59-86°F)
- do not freeze
- protect from light
- Pharmacist: For dispensing, use a light-resistent container with a child-resistant cap
Inactive Ingredient
artificial and natural cherry flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Question Or Comments?
305-592-9216 or [email protected]
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