EXTRA STRENGTH PAIN RELIEVER- acetaminophen tablet

EXTRA STRENGTH PAIN RELIEVER by

Drug Labeling and Warnings

EXTRA STRENGTH PAIN RELIEVER by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 500 mg

PURPOSE

Analgesic, Antipyretic (fever reducer)

INDICATIONS & USAGE

Uses: temporarily relieves minor aches and pains due to: headache common cold toothache backache muscular aches menstrual cramps minor arthritis pain

Temporarily reduces fever

WARNINGS

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 (prescription or non-prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. you have 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening

blisters

rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use: with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

When using this product do not exceed recommended dose.

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 or fever persists or gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: consult a doctor

INACTIVE INGREDIENT

Inactive Ingredients: corn starch, hydroxypropyl methylcelluslose*, maltodextrin*, polyethylen glycol*, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

*contains one or more of these ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-7626
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-7626-6	3 in 1 PACKET	03/15/2019
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/15/2019

Labeler - Mechanical Servants LLC (005530951)