Extra Strength Pain Relief by Preferred Pharmaceuticals, Inc. gc201

Extra Strength Pain Relief by

Drug Labeling and Warnings

Extra Strength Pain Relief by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet 
Preferred Pharmaceuticals, 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.

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gc201

Active Ingredients

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

  • temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tablets 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

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.

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 symptom 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.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children.

Directions

  • do not take more than directed
  • adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
  • children under 12 years: do not use

Other Information

Inactive Ingredients

povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben

Gericare

NDC: 68788-7709

Non-Aspirin

Extra Strength

PAIN RELIEF

Acetaminophen Tablets

Pain Reliever / Fever Reducer

Compare to active ingredient in Extra Strength Tylenol Tablets*

PACKAGE NOT CHILD RESISTANT

500 mg each

Extra Strength APAP Tab 500mg
EXTRA STRENGTH PAIN RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-7709(NDC: 57896-201)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeROUND (Round) Size12mm
FlavorImprint Code M2A457344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-7709-220 in 1 BOTTLE; Type 0: Not a Combination Product06/01/202009/06/2022
2NDC: 68788-7709-330 in 1 BOTTLE; Type 0: Not a Combination Product06/01/202009/06/2022
3NDC: 68788-7709-445 in 1 BOTTLE; Type 0: Not a Combination Product06/01/202009/06/2022
4NDC: 68788-7709-550 in 1 BOTTLE; Type 0: Not a Combination Product06/01/202009/06/2022
5NDC: 68788-7709-660 in 1 BOTTLE; Type 0: Not a Combination Product06/01/202009/06/2022
6NDC: 68788-7709-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/202009/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/01/202009/06/2022
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022REPACK(68788-7709)

Revised: 9/2022