DrugCite

FAMILY WELLNESS ACETAMINOPHEN - acetaminophen tablet 
Family Dollar Services Inc

Family Dollar Services, Inc. Acetaminophen Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

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) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see Liver warning)

adults and children 12 years and over

take 2 caplets every 6 hours while symptoms last
do not take more than 6 caplets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor

children under 12 years

ask a doctor

Other information

store at 20-25ºC (68-77ºF)

Inactive ingredients

carnauba wax*, corn starch*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain one or more of these ingredients

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT OF EXTRA STRENGTH TYLENOL® CAPLETS

Extra Strength

Acetaminophen

Pain Reliever/Fever Reducer

Contains No Aspirin – For Adults

ACTUAL SIZE

500 mg

SEE NEW WARNINGS AND DIRECTIONS

Acetaminophen Carton Image 1
Acetaminophen Carton Image 2

FAMILY WELLNESS ACETAMINOPHEN 
acetaminophen  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 55319-484
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
STARCH, CORN  
HYPROMELLOSES  
POLYETHYLENE GLYCOLS  
POVIDONE  
STEARIC ACID  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (caplet) Size 16mm
Flavor Imprint Code L484
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 55319-484-85 1  In 1 CARTON contains a BOTTLE
1 250  In 1 BOTTLE This package is contained within the CARTON (55319-484-85)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/15/1990

Labeler - Family Dollar Services Inc (024472631)
Revised: 09/2012Family Dollar Services Inc