FDA Label for Medique At Home Diphen
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Medique At Home Diphen Product Label
The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. 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.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient (in each caplet)
Diphenhydramine Hydrochloride 25 mg
Otc - Purpose
Purpose
Antihistamine
Indications & Usage
Uses
■ temporarily relieves these symptoms due to hay fever or other respiratory allergies
■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes
■ temporarily relieves these symptoms due to the common cold
■ runny nose ■ sneezing
Warnings
Warnings
Otc - Do Not Use
Do not use
■ to make a child sleepy
■ with any other product containing diphenhydramine, even one that is used on skin.
Otc - Ask Doctor
Ask a doctor before use if you have
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
■ glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product
■ marked drowsiness may occur
■ avoid alcoholic drinks
■ alcohol, sedatives and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
■ excitability may occur, especially in children
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Dosage & Administration
Directions
■ take every 4 to 6 hours, or as directed by a doctor
■ do not take more than 6 times in 24 hours
Adults and children12 years and over 1 to 2 caplets
Children 6 to under 12 years 1 caplet
Children under 6 years do not use
Other Safety Information
Other information
■ store at room temperature 68°-77°F (20°-25°C)
■ protect from light
■ TAMPER EVIDENT child resistant packets
■ do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
Otc - Questions
Questions or comments? 1-800-634-7680
Package Label.Principal Display Panel
Medique® @ Home
Diphen Caplets
Diphenhydramine HCl 25 mg
Antihistamine
Pull to Open
Child-Resistant Packets
*not actual size
50 Packets
(1 Caplet Per Packet)
Compare to the active ingredient in Benadryl® Ultratab® Tablets
* Please review the disclaimer below.