Extra Strength Pain Relief

Manufacturer
Amerisource Bergen | Aurohealth LLC
Effective date
2019-11-30
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:56:07

Label at a glance#

ProductExtra Strength Pain Relief
Active ingredientACETAMINOPHEN
Label structure15 sections

Indications and 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

Dosage and administration

do not take more than directed (see overdose warning) use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. mL = milliliter adults and children 12 years and over take 30 mL in dose cup provided every 4 to 6 hours while symptoms last do not take more than 120 mL in 24 hours do not take more than 10 days unless directed by a doctor children under 12 years do not use thi...

Storage and handling

each 15 mL contains: sodium 7 mg store at 20-25° C (68-77° F). dosage cup provided do not use if printed shrinkband is missing or broken.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 15 mL)

Acetaminophen USP 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or non-prescription). 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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • mL = milliliter
adults and children 12 years and over
  • take 30 mL in dose cup provided every 4 to 6 hours while symptoms last
  • do not take more than 120 mL in 24 hours
  • do not take more than 10 days unless directed by a doctor
children under 12 years
  • do not use this adult product in children under 12 years of age this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 7 mg
  • store at 20-25° C (68-77° F).
  • dosage cup provided
  • do not use if printed shrinkband is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, D&C Red 33, FD&C red 40, flavors, high fructose corn syrup, non-crystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sucralose. 

Questions or comments?

OTC - QUESTIONS SECTION

1-855-274-4122

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed By:
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
Visit us at www.mygnp.com

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46122-357-34

Rx GOOD NEIGHBOR PHARMACY®

Compare to TYLENOL®

Extra Strength Adult Rapid Blast Cherry

active ingredients*

Extra Strength

Adult

Pain Relief

Adult Acetaminophen oral Liquid 500 mg/15 mL

Pain Reliever, Fever Reducer

Rapid Burst

Cherry Flavor

8 FL OZ

(237 mL)

Do not use if printed shrinkband is missing or broken.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-357-34ML - Milliliter46122-357617a6375-411f-476c-9ffd-53a36e5ddba412017-05-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-35746122-357-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7b57b5e4-7948-41d3-9fc7-6dfa3f94290592452fd4-cdf6-4ff9-8f42-c7d1c79fb7072020-11-19WarningsExact identifier
spl set id: 92452fd4-cdf6-4ff9-8f42-c7d1c79fb707

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.