SOUND BODY PAIN RELIEVER

Main information

  • Trade name:
  • SOUND BODY PAIN RELIEVER- acetaminophen tablet
  • Composition:
  • ACETAMINOPHEN 500 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SOUND BODY PAIN RELIEVER- acetaminophen tablet
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Pain reliever/ fever reducer

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 50594-019-76, 50594-019-78
  • Last update:
  • 03-06-2019

Summary of Product characteristics: dosage, interactions, side effects

SOUND BODY PAIN RELIEVER- acetaminophen tablet

Big Lots Stores, 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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Big Lots, Inc Pain Reliever Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpos e

Pain reliever/fever reducer

Us es

Warnings

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

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

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

Do not use

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

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

skin reddening

blisters

rash

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 have ever had an allergic reaction to this product or any of its ingredients

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

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right

away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you

do not notice any signs or symptoms.

Directions

adults and children 12 years

and over

children under 12 years

ask a doctor

Other information

Inactive ingredients

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone,

pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Questions or comments?

1-800-719-9260

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

do not take more than directed (see overdose warning)

take 2 caplets every 6 hours while symptoms last

do not take more than 6 caplets in 24 hours, unless directed by a

doctor

do not use for more than 10 days unless directed by a doctor

store at 20-25°C (68-77°F)

Principal Display Panel

Compare to the Active Ingredient in Tylenol

Caplets

BONUS 20 MORE FREE

EXTRA STRENGTH

FOR ADULTS

Pain Reliever

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Actual Size

100 + 20 FREE = 120 CAPLETS

SOUND BODY PAIN RELIEVER

acetaminophen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 59 4-0 19

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CARNAUBA WAX (UNII: R12CBM0 EIZ)

STARCH, CO RN (UNII: O8 232NY3SJ)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

16 mm

Flavor

Imprint Code

L48 4

Contains

Packag ing

Big Lots Stores, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 59 4-0 19 -76

1 in 1 CARTON

0 9 /19 /20 16

1

120 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:50 59 4-0 19 -78

1 in 1 CARTON

0 3/18 /20 19

2

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 9 /19 /20 16

Labeler -

Big Lots Stores, Inc. (017885351)

Revised: 4/2019