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NDC 69842-0093-01 Acetaminophen 650 mg/1 Details

Acetaminophen 650 mg/1

Acetaminophen is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. 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: 69842-0093-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	69842-0093
Product ID	69842-093_6d2d12fa-f4f2-494e-a20f-e887a56f35c8
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	Extended Release
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	650
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	CVS Pharmacy
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA207035
Listing Certified Through	n/a

Package

Package Images

NDC 69842-0093-01 (69842009301)

Pricing Information	N/A
NDC Package Code	69842-093-01
Billing NDC	69842009301
Package	100 TABLET in 1 BOTTLE, PLASTIC (69842-093-01)
Marketing Start Date	2020-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f1f47da9-2002-4bc8-8d26-e66b7b403497 Details

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 6 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks ever 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 a 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away. 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 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
children under 12 years of age: ask a doctor

Other information

store between 20-25°C (68-77°F)

Inactive ingredients

D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hydroxyethyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose povidone, pregelatinized starch, sodium lauryl sulfate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient of Tylenol® 8HR Muscle Aches & Pain

Extended-release

Pain Reliever

Acetaminophen 650 mg

Pain reliever/Fever reducer

For up to 8 hours relief of minor muscle aches & pain

Caplets*

(*capsule-shaped bi-layer tablets)

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Muscle Aches & Pain.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy Inc

one CVS Drive, Woonsocket RI 02895

Product Label

CVS HEALTH 8HR Arthritis Pain Relief

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN EXTENDED RELEASE

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-093
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	511
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-093-10	1 in 1 BOX	04/01/2020	04/30/2025
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:69842-093-24	1 in 1 BOX	04/01/2020	04/30/2025
2		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:69842-093-15	1 in 1 BOX	04/01/2020	04/30/2025
3		150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:69842-093-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020	04/30/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207035	04/01/2020	04/30/2025

Labeler - CVS Pharmacy (062312574)

Revised: 11/2022

Document Id: 6d2d12fa-f4f2-494e-a20f-e887a56f35c8

Set id: f1f47da9-2002-4bc8-8d26-e66b7b403497

Version: 4

Effective Time: 20221121