EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet 
Geri-Care Pharmaceutical Corp

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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gc221

Active ingredient

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 caplets 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 caplets every 4-6 hours, as needed; not more than 8 caplets in 24 hours
children under 12 years: ask a doctor

Other Information

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
store at 20⁰C-25⁰C (68⁰F-77⁰F)
for institutional use only

Inactive ingredients

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

Package label

GERICARE

NDC 57896-221-01

Non-Aspirin

Extra Strength

PAIN RELIEF

Acetaminophen Caplets

Pain Reliever / Fever Reducer

Compare to active ingredients in Extra Strength Tylenol Caplets*

PACKAGE NOT CHILD RESISTANT

Caplets 500 mg

Repackaged By: Preferred Pharmaceuticals Inc.

Extra Strength Acetaminophen 500mg
EXTRA STRENGTH PAIN RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7620(NDC:57896-221)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeCAPSULE (Capsule) Size15mm
FlavorImprint Code M2A457344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7620-220 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
2NDC:68788-7620-330 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
3NDC:68788-7620-445 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
4NDC:68788-7620-550 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
5NDC:68788-7620-660 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
6NDC:68788-7620-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/18/2020
Labeler - Geri-Care Pharmaceutical Corp (791119022)
Registrant - Geri-Care Pharmaceutical Corp (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Geri-Care Pharmaceutical Corp791119022REPACK(68788-7620)

Revised: 5/2020
 
Geri-Care Pharmaceutical Corp