Equate Pain Reliever Acetaminophen For Adults 250 Mg

Equate Pain Reliever Acetaminophen For Adults 250 Mg
SPL v2
SPL
SPL Set ID 0d106fa2-2a77-deb2-e063-6394a90a2dac
Route
ORAL
Published
Effective Date 2024-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Povidone K30 Corn Syrup Hydroxypropyl Betadex Neotame Ammonium Glycyrrhizate Glyceryl Mono And Dipalmitostearate Sucralose Sodium Chloride Carrageenan Trisodium Citrate Dihydrate Sucrose Maltitol Maltodextrin Levomenthol Fd&c Yellow No. 6 Water Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: O Shape: rectangle Color: orange Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Acetaminophen 250mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 250mg

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
Section 42229-5

U.S. Patent 11,273,123

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • a sodium-restricted diet
Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Warnings

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

  • more than 4,000mg of acetaminophen in 24 hours, which is the maximum daily amount
  • 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

Directions
  • do not give more than directed (see overdose warning)
 Age (yrs.) Dose (chewable bar)
 Adults and children 12 years and over
  • take 4 chewable bars every 6 hours while symptoms last
  • do not take more than 12 chewable bars 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

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.
Other Information
  • each chewable bar contains: potassium 5mg, sodium 16mg.
  • Store in a cool dry place between 20-25°C (68-77°F).
  • Child Resistant Container;do not use if printed seal under cap is broken or missing.
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.

Inactive Ingredients:

ammonium glycyrrhizate, FD & C yellow #6, flavors, geleol mono and diglycerides, glucose syrup, hydroxypropyl betadex, maltitol solution, maltodextrin, menthol, neotame, polyethylene glycol 400, povidone, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

Questions Or Comments?

Call 1-888-287-1915

Active Ingredient (in Each Chewable Bar)

Acetaminophen 250mg

Principal Display Panel Equate Pain Reliever Acetaminophen for Adults 250 Mg Orange Vanilla Flavor

NDC 79903-247-40

equate™

Compare to Tylenol ®active ingredient**

Pain Reliever Acetaminophen for Adults 250 mg

Pain Reliever/Fever Reducer

Contains No Aspirin

Soft Chew Bars

Orange Vanilla Flavor

250 mg EACH 40 CHEWABLE BARS

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


Structured Label Content

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
Section 42229-5 (42229-5)

U.S. Patent 11,273,123

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • a sodium-restricted diet
Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Pain reliever/fever reducer

Warnings

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

  • more than 4,000mg of acetaminophen in 24 hours, which is the maximum daily amount
  • 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

Directions
  • do not give more than directed (see overdose warning)
 Age (yrs.) Dose (chewable bar)
 Adults and children 12 years and over
  • take 4 chewable bars every 6 hours while symptoms last
  • do not take more than 12 chewable bars 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

Do Not Use (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.
Other Information (Other information)
  • each chewable bar contains: potassium 5mg, sodium 16mg.
  • Store in a cool dry place between 20-25°C (68-77°F).
  • Child Resistant Container;do not use if printed seal under cap is broken or missing.
Overdose Warning: (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.

Inactive Ingredients: (Inactive ingredients:)

ammonium glycyrrhizate, FD & C yellow #6, flavors, geleol mono and diglycerides, glucose syrup, hydroxypropyl betadex, maltitol solution, maltodextrin, menthol, neotame, polyethylene glycol 400, povidone, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

Questions Or Comments? (Questions or comments?)

Call 1-888-287-1915

Active Ingredient (in Each Chewable Bar) (Active ingredient (in each chewable bar))

Acetaminophen 250mg

Principal Display Panel Equate Pain Reliever Acetaminophen for Adults 250 Mg Orange Vanilla Flavor (Principal Display Panel - Equate Pain Reliever Acetaminophen for Adults 250 mg-Orange Vanilla Flavor)

NDC 79903-247-40

equate™

Compare to Tylenol ®active ingredient**

Pain Reliever Acetaminophen for Adults 250 mg

Pain Reliever/Fever Reducer

Contains No Aspirin

Soft Chew Bars

Orange Vanilla Flavor

250 mg EACH 40 CHEWABLE BARS

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


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