Otc - Active Ingredient
Active Ingredients (in each tablet)
Diphenhydramine Hydochloride 25 mg
Physicianscare Allergy Tablet, Film Coated
FDA Label NDC 0924-0056
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product Physicianscare Allergy (NDC 0924-0056). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, information for patients, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antihistamine
Indications & Usage
Uses
temporarily relieves these symptoms due to hay fever or other respiratory allergies
- runny nose
- sneezing
- itching nose or throat
- itchy-watery eyes
- runny nose
- sneezing
temporarily relieves these symptoms due to the common cold
Warnings
Warnings
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one that is used on the skin.
- a breathing problem such as emphysema or chronic bronchitis
- difficuly in urination due to enlargement of the prostate gland
- glaucoma
- taking sedatives or tranquilizers
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
* marked drowsiness may occur and avoid alcoholic beverages
* alcohol, sedatives and tranquilizers may increase the drowsiness effect
* use caution when driving a motor vehicle or operating machinery
* excitability may occur, especially in children
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, contact a physician or poison control center immediately.
Dosage & Administration
Directions
Do not use more than directed
Adults and children: (12 years and older)
Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.
Children under 12 years:
Do not give to children under 12 years of age.
Information For Patients
Other information
- each caplet may contain: calium 25mg
- store at room temperature 59°-86°F (15°-30°C)
- protect from light
- use by expiration date on packet
- tamper-evident sealed packets
- do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide
*may contain.
Otc - Questions
Questions?
1-800-835-2263
Package Label.Principal Display Panel
BOX16790056-revC.jpg
Carton 167 (Box16790056 Revc)
Carton184 (Box18490036 Revc)
* Please review the disclaimer below.
