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

CareOne Allergy Medication Image 1
CareOne Allergy Medication Image 2
CAREONE ALLERGY MEDICATION 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-361
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorPINK (dark) Scoreno score
ShapeCAPSULESize10mm
FlavorImprint Code L479
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-361-6224 in 1 CARTON05/24/200406/27/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41520-361-6836 in 1 CARTON05/24/200406/27/2018
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41520-361-781 in 1 CARTON05/24/200406/27/2018
3100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/24/200406/27/2018
Labeler - American Sales Company (809183973)

Revised: 10/2018
Document Id: 5c7d5e5c-a558-4363-bbe1-c41c182bef78
Set id: 0be2f9dc-674b-4982-89e8-23d16a12553f
Version: 3
Effective Time: 20181019
 
American Sales Company