sound body 44-773 delisted

sound body 44-773 delisted
SPL v4
SPL
SPL Set ID 5f32a3f8-859d-4dca-aa25-3636eefd7cbc
Route
oral
Published
Effective Date 2024-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides (25 mg)
Inactive Ingredients
starch, corn dibasic calcium phosphate dihydrate fd&c blue no. 1 aluminum lake hypromellose, unspecified magnesium stearate medium-chain triglycerides microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified silicon dioxide sodium lauryl sulfate sucrose talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L7 Shape: round Color: blue Size: 10 mm Score: 1
Marketing Status
otc monograph drug completed Since 2022-07-05 Until 2025-10-25

Purpose

Stimulant laxative

Description

Sennosides USP, 25 mg


Medication Information

Active Ingredient

Sennosides USP, 25 mg

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 6 to 12 hours

Purpose

Stimulant laxative

Directions
  • do not take more than directed
  • swallow tablet(s) with a glass of water
  • swallow tablet(s) whole; do not crush, break, or chew

adults and children 12 years and over 2 tablets once or twice daily

children 6 to under 12 years

1 tablet once or twice daily

children under 6 years

ask a doctor
Other Information
  • each tablet contains: calcium 35 mg

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive Ingredients

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium lauryl sulfate, sucrose, talc, titanium dioxide

Description

Sennosides USP, 25 mg

Principal Display Panel

SOUNDBODY

*Compare to the

active ingredient

in ex•lax®

Maximum Strength

NDC 50844-073-08

MAXIMUM STRENGTH

Laxative

Sennosides USP, 25 mg

Stimulant Laxative

Gentle, Dependable Constipation Relief

24 TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or

distributed by GSK Consumer Healthcare SARL,

owner of the registered trademark ex•lax®

Maximum Strength.

50844         ORG082177308

Manufactured for

Big Lots Stores, Inc.

by LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY

11788 USA

V#733000

ITEM#022777308BLBX

Sound Body 44-773
Do Not Use

laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Questions Or Comments?

1-800-426-9391

When Using This Product,

do not use for a period longer than 1 week.

Stop Use and Ask A Doctor If

rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Sennosides USP, 25 mg

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 6 to 12 hours

Purpose

Stimulant laxative

Directions
  • do not take more than directed
  • swallow tablet(s) with a glass of water
  • swallow tablet(s) whole; do not crush, break, or chew

adults and children 12 years and over 2 tablets once or twice daily

children 6 to under 12 years

1 tablet once or twice daily

children under 6 years

ask a doctor
Other Information (Other information)
  • each tablet contains: calcium 35 mg

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium lauryl sulfate, sucrose, talc, titanium dioxide

Principal Display Panel (Principal display panel)

SOUNDBODY

*Compare to the

active ingredient

in ex•lax®

Maximum Strength

NDC 50844-073-08

MAXIMUM STRENGTH

Laxative

Sennosides USP, 25 mg

Stimulant Laxative

Gentle, Dependable Constipation Relief

24 TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or

distributed by GSK Consumer Healthcare SARL,

owner of the registered trademark ex•lax®

Maximum Strength.

50844         ORG082177308

Manufactured for

Big Lots Stores, Inc.

by LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY

11788 USA

V#733000

ITEM#022777308BLBX

Sound Body 44-773
Do Not Use (Do not use)

laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Questions Or Comments? (Questions or comments?)

1-800-426-9391

When Using This Product, (When using this product,)

do not use for a period longer than 1 week.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.

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.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.


Advanced Ingredient Data


Raw Label Data

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