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NDC 00113-7000-78 Basic Care acetaminophen 500 mg/1 Details

Basic Care acetaminophen 500 mg/1

Basic Care acetaminophen is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 00113-7000-78
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	00113-7000
Product ID	0113-7000_7ae8ac2b-9214-4341-b6bd-53f1742b4668
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Basic Care acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	L. Perrigo Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00113-7000-78 (00113700078)

Pricing Information	N/A
NDC Package Code	0113-7000-78
Billing NDC	00113700078
Package	1 BOTTLE in 1 CARTON (0113-7000-78) / 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2018-10-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 50b761b3-4823-4489-a934-2109cfb2824e Details

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

•: temporarily relieves minor aches and pains due to:
•: headache
•: muscular aches
•: backache
•: minor pain of arthritis
•: the common cold
•: toothache
•: 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 20-25°C (68-77°F)
•: do not use if printed seal under cap is broken or missing

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, mica-based pearlescent pigment, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Tylenol® Rapid Release Gels active ingredient

Extra Strength

Rapid Release

acetaminophen

Pain Reliever/Fever Reducer

Fast Relief / For Adults

actual size

100 CAPLETS-500 mg Each

INGREDIENTS AND APPEARANCE

BASIC CARE ACETAMINOPHEN

acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-7000
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	3S0
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0113-7000-79	400 in 1 BOTTLE; Type 0: Not a Combination Product	08/10/2017
2	NDC:0113-7000-78	1 in 1 CARTON	10/08/2018
2		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	08/10/2017

Labeler - L. Perrigo Company (006013346)

Revised: 2/2019

Document Id: 7ae8ac2b-9214-4341-b6bd-53f1742b4668

Set id: 50b761b3-4823-4489-a934-2109cfb2824e

Version: 3

Effective Time: 20190206