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NDC 11822-4484-01 acetaminophen 500 mg/1 Details

acetaminophen 500 mg/1

acetaminophen is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid Corporation. 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: 11822-4484-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	11822-4484
Product ID	11822-4484_bc03458c-885a-43f7-b05d-101a20aeb4ab
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	acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Rite Aid Corporation
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 11822-4484-01 (11822448401)

Pricing Information	N/A
NDC Package Code	11822-4484-1
Billing NDC	11822448401
Package	1 BOTTLE in 1 CARTON (11822-4484-1) / 225 TABLET in 1 BOTTLE
Marketing Start Date	2020-09-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a8bb4f45-7a1a-4bf7-92ca-3afd508032f3 Details

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 20-25°C (68-77°F)

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

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of Extra Strength Tylenol® Caplets

FREE FROM

GLUTEN FREE

CAFFEINE FREE

EXTRA STRENGTH

ACETAMINOPHEN

ACETAMINOPHEN CAPLETS, 500 mg

ACTUAL SIZE

PAIN RELIEVER/FEVER REDUCER

For adults

225 CAPLETS

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-4484
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

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:11822-4484-1	1 in 1 CARTON	09/08/2020
1		225 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:11822-4484-2	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2020
3	NDC:11822-4484-3	1 in 1 CARTON	07/01/2022
3		24 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:11822-4484-4	1 in 1 CARTON	07/11/2022
4		50 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:11822-4484-5	1 in 1 CARTON	07/11/2022
5		100 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:11822-4484-6	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	09/04/2020

Labeler - Rite Aid Corporation (014578892)

Revised: 7/2022

Document Id: bc03458c-885a-43f7-b05d-101a20aeb4ab

Set id: a8bb4f45-7a1a-4bf7-92ca-3afd508032f3

Version: 4

Effective Time: 20220711