SOUND BODY EXTRA STRENGTH PAIN RELIEVER- acetaminophen 500 mg tablet

Sound Body Extra Strength Pain Reliever by

Drug Labeling and Warnings

Sound Body Extra Strength Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

• the common cold
• headache
• backache
• minor pain of arthritis
• toothache
• muscular aches
• premenstrual and menstrual cramps temporarily reduces fever

Warnings

 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if

the user is 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 symptoms occur
• redness or swelling is present

These could be signs of a serious condition

• You may report side effects to 1-888-952-0050

If pregnant 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Directions

• do not take more than directed (see overdose warning)

Adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last

• do not take more than 8 caplets in 24 hours, unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor 

Children under 12 years of age: ask a doctor

Other information

• store between 20º-25ºC (68º-77ºF)
• do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-888-952-0500

Principal Display Panel

SOUNDBODY™

Compare to the Active Ingredient in Tylenol® Caplets*

EXTRA STRENGTH

See New Warnings Information

Pain Reliever

Acetaminophen 500mg

Pain Reliever/Fever Reducer

100 Caplets

(pill image) Actual Size

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.

Distributed by:
Allegiant Health
Deer Park, NY 11729

V#5003620 ITEM#FP0638

LB1299
R0617

Pain Relief EX 100ct. Caplets

Pain Relief EX 100ct. Caplets

INGREDIENTS AND APPEARANCE

SOUND BODY EXTRA STRENGTH PAIN RELIEVER 
acetaminophen 500 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-913
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	AZ012
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-913-01	1 in 1 CARTON	12/17/2014
1		100 in 1 BOTTLE; 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	12/17/2014

Labeler - Allegiant Health (079501930)