Extra Strength Pain Relief (Acetaminophen) Tablet [St. Mary's Medical Park Pharmacy] -

EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [ST. MARY'S MEDICAL PARK PHARMACY]
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NDC	60760-222-40
Set ID	65584446-0bd7-6ca7-e053-2a91aa0ac4df
Category	HUMAN OTC DRUG LABEL
Packager	St. Mary's Medical Park Pharmacy
Generic Name
Product Class
Product Number
Application Number	PART343

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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

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEF
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60760-222(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	Marketing End Date
Packaging
1	NDC:60760-222-40	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/16/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	02/16/2018

Labeler - St. Mary's Medical Park Pharmacy (063050751)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Name	Address	ID/FEI	Business Operations
Establishment
St. Mary's Medical Park Pharmacy		063050751	relabel(60760-222) , repack(60760-222)

Name	Address	ID/FEI	Business Operations
Establishment
Geri-Care Pharmaceutical Corp		611196254	repack(60760-222)

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Medic

Inactive ingredients