FDA Label for Onessip Diphenhydramine Hcl 12.5 Mg/ 5 Ml Oral Solution (cherry)
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTION OR COMMENTS?
- RECENT MAJOR CHANGES
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Onessip Diphenhydramine Hcl 12.5 Mg/ 5 Ml Oral Solution (cherry) Product Label
The following document was submitted to the FDA by the labeler of this product Medwise Lifesciences Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
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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