AMAZON BASIC CARE ACETAMINOPHEN- acetaminophen tablet

AMAZON BASIC CARE ACETAMINOPHEN by

Drug Labeling and Warnings

AMAZON BASIC CARE ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by Amazon.com Services LLC, Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP 325 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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 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 DOCTOR

Ask a doctor before use if the user has liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• 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.

PREGNANCY OR BREAST FEEDING

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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
• children 6 years to under 12 years:
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
• children under 6 years: ask a doctor

Other information

• store between 20° to 25°C (68° to 77°F)
• do not use if carton is open or if printed foil seal under bottle cap is open or torn.

Inactive ingredients

povidone, pregelatinized starch (maize), stearic acid

Questions or comments?

call 1-855-274-4122

DISTRIBUTED BY:
AMAZON.COM SERVICES LLC
410 TERRY AVENUE N., SEATTLE, WA 98109

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle)

amazon
basic+care

Regular Strength
NDC: 72288-405-10

Acetaminophen
Tablets 325 mg
Pain Reliever/
Fever Reducer

DO NOT USE WITH
OTHER MEDICINES
CONTAINING
ACETAMINOPHEN

100 TABLETS
325 mg EACH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle Carton)

amazon
basic+care

Regular Strength NDC: 72288-405-10

Compare to
Regular Strength
Tylenol® Tablets
active ingredient*

Acetaminophen
Tablets 325 mg
Pain Reliever/Fever Reducer

100 TABLETS
325 mg EACH         DO NOT USE WITH OTHER MEDICINES
                                 CONTAINING ACETAMINOPHEN

INGREDIENTS AND APPEARANCE

AMAZON BASIC CARE ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-405
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M)

Product Characteristics
Color	WHITE (White to off White)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	N74
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-405-10	1 in 1 CARTON	05/15/2024
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	05/15/2024

Labeler - Amazon.com Services LLC (128990418)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650844777	ANALYSIS(72288-405) , MANUFACTURE(72288-405)