Extra Strength Pain Relief by NuCare Pharmaceuticals, Inc.

Drug Details [pdf]

EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet
NuCare 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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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

PDP Dist. By: Gericare Pharmaceuticals Corp.

1650 63rd Street

Brooklyn,NY 11204

EXTRA STRENGTH PAIN RELIEF
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66267-005(NDC: 57896-221)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 68401960MK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	CAPSULE (Capsule)	Size	15mm
Flavor		Imprint Code	M2A457344
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 66267-005-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2016
2	NDC: 66267-005-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2016
3	NDC: 66267-005-45	45 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2016
4	NDC: 66267-005-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	09/21/2016	12/31/2018

Labeler - NuCare Pharmaceuticals, Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals, Inc.		010632300	repack(66267-005)

Revised: 3/2020

Document Id: a1b5f4af-6719-82c6-e053-2a95a90ad5fc

Set id: 3d062e3b-bf16-20be-e054-00144ff8d46c

Version: 4

Effective Time: 20200325