OTC Medication Information: Acetaminophen Gelcaps Extra Strength

ACETAMINOPHEN GELCAPS EXTRA STRENGTH- acetaminophen tablet, coated
Supervalu Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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

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

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

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 20-25ºC (68-77ºF)
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

Equaline®

NDC 41163-520-03

compare to Extra Strength Tylenol® Rapid Release Gels active ingredient*

extra strength

acetaminophen gelcaps

500mg

rapid release

pain reliever/fever reducer — fast release — aspirin free

100 gelcaps

image description
(click image for full-size original)
ACETAMINOPHEN GELCAPS EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-520
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color gray (red and light blue ends) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code G1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41163-520-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 24 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41163-520-01)
2 NDC:41163-520-02 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 50 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41163-520-02)
3 NDC:41163-520-03 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
3 100 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41163-520-03)
4 NDC:41163-520-07 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
4 150 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41163-520-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 10/01/2014
Labeler — Supervalu Inc. (006961411)

Revised: 10/2019 Supervalu Inc.

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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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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