CAREONE ALLERGY MEDICATION- diphenhydramine hydrochloride tablet 
American Sales Company

Disclaimer: 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.

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American Sales Company Allergy Medication Drug Facts

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 Type HUMAN OTC DRUG Item Code (Source) NDC:41520-361
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
Color PINK (dark) Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code L479
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-361-62 2 in 1 CARTON
1 12 in 1 BLISTER PACK
2 NDC:41520-361-68 3 in 1 CARTON
2 12 in 1 BLISTER PACK
3 NDC:41520-361-78 1 in 1 CARTON
3 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/24/2004
Labeler - American Sales Company (809183973)

Revised: 8/2013
Document Id: 0be2f9dc-674b-4982-89e8-23d16a12553f
Set id: 0be2f9dc-674b-4982-89e8-23d16a12553f
Version: 1
Effective Time: 20130828
 
American Sales Company