Search by Drug Name or NDC

NDC 69842-0465-12 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 CVS Pharmacy, Inc.. 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: 69842-0465-12
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	69842-0465
Product ID	69842-465_b596a958-49b5-1ac7-e053-2995a90a52f0
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	CVS Pharmacy, Inc.
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 69842-0465-12 (69842046512)

Pricing Information	N/A
NDC Package Code	69842-465-12
Billing NDC	69842046512
Package	1 BOTTLE in 1 CARTON (69842-465-12) / 100 TABLET in 1 BOTTLE
Marketing Start Date	2018-08-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6dea9e11-ff99-63c7-e053-2a91aa0a5b54 Details

Drug Facts

Active ingredient (in each tablet)

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

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 are allergic to acetaminophen or any of the inactive ingredients in this product.

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 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 tablets every 6 hours while symptoms last

■ do not take more than 6 tablets 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)

■ see end flap for expiration date and lot number

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate and stearic acid

Questions or comments?

1-800-231-4670

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by McNeil

Consumer Healthcare, owner of the registered trademark

Extra Strength Tylenol®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

1-800-SHOP CVS V-34571

PRINCIPAL DISPLAY PANEL

CVSHealth

Compare to the active ingredient in Extra Strength Tylenol®*

EXTRA STRENGTH

Acetaminophen

Tablets 500 mg

Pain reliever; Fever reducer

Aspirin free

100 TABLETS

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-465
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
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	CPC;546
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-465-12	1 in 1 CARTON	08/06/2018
1		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	08/06/2018

Labeler - CVS Pharmacy, Inc. (062312574)

Revised: 12/2020

Document Id: b596a958-49b5-1ac7-e053-2995a90a52f0

Set id: 6dea9e11-ff99-63c7-e053-2a91aa0a5b54

Version: 3

Effective Time: 20201203