OTC Medication Information: Acetaminophen Extra Strength

ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet
Family Dollar Stores, LLC

Active ingredient (in each gelcap)

Acetaminophen USP 500 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. 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.

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 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps 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

Other information

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

Inactive ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), propylene glycol, shellac glaze, sodium starch glycolate, talc and titanium dioxide.

Questions or comments?

1-855-274-4122

DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA
Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Gelcaps Container Label)

FAMILY
Wellness
EXTRA STRENGTH
PAIN RELIEF
Acetaminophen Gelcaps
500 mg
Pain Reliever, Fever Reducer
Rapid Release Gels
FOR ADULTS
100 GELCAPS 500 mg Each NDC 55319-053-21

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Label)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Gelcaps Container Carton)

FAMILY
Wellness
COMPARE TO THE ACTIVE
INGREDIENT IN EXTRA STRENGTH
TYLENOL RAPID RELEASE GELS*

EXTRA STRENGTH
PAIN RELIEF RAPID
RELEASE
Acetaminophen Gelcaps, 500 mg
Pain Reliever, Fever Reducer
Rapid Release Gels
FOR ADULTS ACTUAL SIZE
100 GELCAPS DO NOT USE WITH OTHER MEDICINES 500 mg Each CONTAINING ACETAMINOPHEN NDC 55319-053-21

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Carton)
(click image for full-size original)

ACETAMINOPHEN EXTRA STRENGTH acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-053
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
FERROSOFERRIC OXIDE
SILICON DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
FD&C RED NO. 40
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
PROPYLENE GLYCOL
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color red (and Blue with Grey Band) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code J;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55319-053-14 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 TABLET in 1 BOTTLE This package is contained within the CARTON (55319-053-14)
2 NDC:55319-053-21 1 BOTTLE in 1 CARTON contains a BOTTLE
2 100 TABLET in 1 BOTTLE This package is contained within the CARTON (55319-053-21)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 08/11/2023
Labeler — Family Dollar Stores, LLC (024472631)
Registrant — Aurohealth LLC (078728447)
Establishment
Name Address ID/FEI Operations
APL HEALTHCARE LIMITED 650844777 analysis (55319-053), manufacture (55319-053)

Revised: 12/2023 Family Dollar Stores, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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