Your browser does not support JavaScript! CAREONE ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

CAREONE ALLERGY MEDICATION (diphenhydramine hydrochloride) tablet
[American Sales Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient (in each tablet)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy, watery eyes
itchy nose or throat
temporarily relieves these symptoms of the common cold:
runny nose
sneezing

Warnings

Do not use

with any other product containing diphenhydramine, even one used on skin
to make a child sleepy

Ask a doctor before use if you have

glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

marked drowsiness may occur
avoid alcoholic drinks
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take every 4 to 6 hours, not more than 6 doses in 24 hours

adults and children 12 years of age and over

1 or 2 tablets

children 6 to under 12 years of age

1 tablet

children 4 to under 6 years of age

do not use unless directed by a doctor

children under 4 years of age

do not use

Other information

each tablet contains: calcium 20 mg
store at 20°-25°C

Inactive ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Benadryl® Allergy Ultratab®

ALLERGY MEDICATION

Small Tablet Size

Diphenhydramine Hydrochloride 25 mg – Antihistamine

EASY TO SWALLOW

For Allergy Relief

Sneezing – Itchy, Watery Eyes

Runny Nose – Itchy Throat

100 TABLETS

American Sales Company Allergy Medication.jpg
American Sales Company Allergy Medication.jpg
CAREONE ALLERGY MEDICATION 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-361
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSPOVIDONE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
STEARIC ACID 
TITANIUM DIOXIDE 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
Product Characteristics
ColorPINK (dark) Scoreno score
ShapeCAPSULESize10mm
FlavorImprint Code L479
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-361-622 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:41520-361-683 in 1 CARTON
212 in 1 BLISTER PACK
3NDC:41520-361-781 in 1 CARTON
3100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/24/2004
Labeler - American Sales Company (809183973)

Revised: 8/2013
 
American Sales Company

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services