Regular strength pain relief capsule, liquid filled

Spl unclassified section

Drug Facts

Active ingredient (in each softgel)

Acetaminophen 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 softgels (3,250 mg) in 24 hours for adults or 5 softgels (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

Otc - ask doctor section

Ask a doctor before use if the user hasliver disease

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if the user istaking 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.

Otc - pregnancy or breast feeding section

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

Otc - keep out of reach of children section

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 softgels every 4 to 6 hours while symptoms last
  • do not take more than 10 softgels in 24 hours
  • do not use for more than 10 days unless directed by a doctor

children 6-11 years

  • take 1 softgel every 4 to 6 hours while symptoms last
  • do not take more than 5 softgels 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 at room temperature 15-30C (59-86F)

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Questions or comments?

Call toll free: 1-888-423-0139

Ingredients and appearance - Product information

Regular strength pain relief capsule, liquid filled- Acetaminophen

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 36800-435
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
Fd&c red no. 40 ( UNII: WZB9127XOA)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Gelatin ( UNII: 2G86QN327L)
Glycerin ( UNII: PDC6A3C0OX)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Povidone ( UNII: FZ989GH94E)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sorbitol ( UNII: 506T60A25R)

Product Characteristics

Color red (clear) Shape capsule (oblong)
Size 20 mm Score 1
Imprint Code PC17

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part343 USA

Labeler - Topco Associates LLC( 006935977)

Establishment

Name ID/FEI Business Operations
Topco Associates LLC 006935977 manufacture( 36800-435), analysis( 36800-435)

Principal display panel

TopCare REGULAR STRENGTH Pain Relief

Acetaminophen 325 mg 40 SOFTGELS

NDC 36800-435-25

*Compare to the active ingredient in TYLENOL ®Regular Strength