ACETAMINOPHEN CAPLETS- acetaminophen tablet

Acetaminophen Caplets by

Drug Labeling and Warnings

Acetaminophen Caplets by is a Otc medication manufactured, distributed, or labeled by Breeden Brothers, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Drug Facts (continued)

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: _ rash _ blisters

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

Do not use

_ if you are allergic to acetaminophen or any of the inactive ingredients in this product

_ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug

Drug Facts (continued)

contains acetaminophen, ask a doctor or pharmacist.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is

Drug Facts (continued)

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

_ 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 take for more than 10 days unless directed by a doctor

_ children under 12 years: ask a doctor

Other information

_ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

_ use by expiration date on package

Drug Facts (continued)

Inactive ingredients

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

1-800-901-2420

Dist. by Breeden Brothers, LLC
Nashville, TN 37219

PRINCIPAL DISPLAY PANEL

b+b
better by giving
EXTRA STRENGTH
PAIN RELIEVER
acetaminophen
Pain Reliever/Fever Reducer
50 Caplets
(500 mg each)

PRINCIPAL DISPLAY PANEL

b+b
NDC: 70729-175-12
EXTRA STRENGTH
PAIN RELIEVER
acetaminophen 500 mg
Pain Reliever/Fever Reducer
100 Caplets

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN CAPLETS 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70729-001
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;175
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70729-001-24	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2017
2	NDC: 70729-001-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	05/01/2017

ACETAMINOPHEN CAPLETS 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70729-175
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;175
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70729-175-12	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	05/01/2017

Labeler - Breeden Brothers, LLC (080131046)