Pain Relief Extra Strength (Acetaminophen) Tablet [Publix Super Markets Inc] -

PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [PUBLIX SUPER MARKETS INC]
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NDC	56062-484-71, 56062-484-78, 56062-484-83
Set ID	dd01adcd-26a1-416e-92fc-8b6c0cc5512e
Category	HUMAN OTC DRUG LABEL
Packager	Publix Super Markets Inc
Generic Name
Product Class
Product Number
Application Number	PART343

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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. 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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

•

skin reddening

•

blisters

•

rash

If a skin reaction occurs, stop use and seek medical help right away.

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.

Overdose warning: 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 overdose 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*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients
Principal Display Panel

EXTRA STRENGTH

pain relief

ACETAMINOPHEN 500 mg

Pain reliever/fever reducer

For adults

ACTUAL SIZE

250 CAPLETS

Compare to Extra Strength Tylenol® Caplets active ingredient

INGREDIENTS AND APPEARANCE

PAIN RELIEF EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56062-484
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	L484
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:56062-484-78	1 in 1 CARTON	09/15/1988
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:56062-484-71	1 in 1 CARTON	09/15/1988
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:56062-484-83	1 in 1 CARTON	03/09/2018
3		225 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:56062-484-85	1 in 1 CARTON	03/20/2000
4		250 in 1 BOTTLE; Type 0: Not a Combination Product