Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Onessip Diphenhydramine Hcl 12.5 Mg/ 5 Ml Oral Solution (cherry) Solution
FDA Label NDC 87078-421
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medwise Lifesciences Inc. for the product Onessip Diphenhydramine Hcl 12.5 Mg/ 5 Ml Oral Solution (cherry) (NDC 87078-421). 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), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, 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
Warnings
Warnings
Otc - Do Not Use
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
Ask a doctor before use if the child has
- a breathing problem such as chronic bronchitis
- glaucoma
- a sodium-restricted diet
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers.
Otc - When Using
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Otc - 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. (1-800-222-1222)
Directions
- mL = milliliter
- take every 4 to 6 hours or as directed by a doctor
- do not take more than 6 doses (6 sachets) in 24 hours
- follow the instruction given on this carton for your easy use
| Age (years) | Dose (mL) |
| Children under 2 Years | do not use |
| Children 2 to 5 Years | do not use unless directed by doctor |
| Children 6 to 11 Years | 1 Sachet (5 mL) to 2 Sachets (10 mL) |
Other Information
- store between 20-25°C (68-77°F)
- Do not use if carton or sachet is torn, broken or punctured.
Inactive Ingredients
Sorbitol, sodium benzoate, sucralose, citric acid anhydrous, sodium citrate, flavor, FD&C Red No. 40, xanthan gum, glycerin, sodium saccharin, sodium EDTA, water.
Question Or Comments?
call 1-516-675-8915
Recent Major Changes
Addition of picture
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