Otc - Active Ingredient
Active ingredient (in each tablet)
Diphenhydramine HCl 25 mg
Allergy, Lil Drug Store Tablet, Coated
FDA Label NDC 66715-6914
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Allergy, Lil Drug Store (NDC 66715-6914). 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, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
- sneezing
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
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 you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
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 beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
| adults and children 12
years and over | 1 to 2 tablets |
| children 6 to under 12
years | 1 tablet |
| children under 6 years | do not use |
Other Information
- each tablet contains: calcium 30 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide
Questions Or Comments?
Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)
Package Label.Principal Display Panel
[caduceus] *Compare to the Active Ingredient
in Benadryl
® Allergy ULTRATAB
® Tablets
Allergy
Diphenhydramine HCI 25 mg
Antihistamine
Relieves
• Runny Nose • Sneezing
[tablet image]
• Itchy, Watery Eyes ACTUAL SIZE
• Itchy Nose or Throat
36
Tablets
[Lil' Drug Store logo]
RELIEVES SYMPTOMS OF HAY FEVER & OTHER ALLERGIES
Compare to the active ingredient in
Benadryl
® Allergy ULTRATAB® Tablets*
CIRCLE K
multi-symptom
allergy
Diphenhydramine HCI 25 mg,
Antihistamine
[tablet image]
actual size
36 tablets
* Please review the disclaimer below.
