REGULAR STRENGTH PAIN RELIEF- acetaminophen tablet

Regular Strength Pain Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Acetaminophen 325 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

Do not use

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

• more than 12 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
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  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.

  • 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

Keep out of reach of children.

Directions

• do not take more than directed
  

• adults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 12 tablets 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

INGREDIENTS AND APPEARANCE

REGULAR STRENGTH PAIN RELIEF 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66267-999(NDC: 57896-101)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
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	2 pieces
Shape	ROUND (Round)	Size	10mm
Flavor		Imprint Code	M2A357344
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66267-999-00	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/01/1989	12/31/2018

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	relabel(66267-999)