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careone allergy relief by American Sales Company

Medically reviewed on Sep 21, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: American Sales Company
NDC Code: 41520-778

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.

American Sales Company Allergy Relief Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy, watery eyes
itching of the 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
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful 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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses 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 20 mg
store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.

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 active ingredient in Benadryl® Allergy Ultratabs®

Easy To Swallow

Allergy Relief

Diphenhydramine Hydrochloride Tablets, 25 mg

Antihistamine

Actual Size

100 TABLETS

FOR ALLERGY RELIEF OF:

Sneezing – Runny Nose

Itchy, Watery Eyes – Itchy Throat

Gluten Free

CAREONE ALLERGY RELIEF 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-778
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 (15 MPA.S AT 5%) 
D&C RED NO. 27 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
STEARIC ACID 
TITANIUM DIOXIDE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
Product Characteristics
ColorPINK (dark) Scoreno score
ShapeCAPSULESize10mm
FlavorImprint CodeL479;25
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-778-6224 BLISTER PACK in 1 CARTON
11 TABLET in 1 BLISTER PACK
2NDC:41520-778-781 BOTTLE in 1 CARTON
2100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/21/2017
Labeler - American Sales Company (809183973)

 
American Sales Company

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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