Equaline Regular Strength Chocolated Stimulant Laxative Tablet, Chewable
FDA Label NDC 83455-300

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Equaline Regular Strength Chocolated Stimulant Laxative (NDC 83455-300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each piece of 12 piece block), purpose, uses, otc - do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Piece Of 12 Piece Block)

Sennosides, USP, 15 mg

Purpose

Stimulant laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours

Otc - Do Not Use

Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

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.

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - 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 (1-800-222-1222) right away.

Directions

adults and children 12 years of age and older chew 2 chocolated pieces once or twice daily
children 6 to under 12 years of age chew 1 chocolated piece once or twice daily
children under 6 years of age ask a doctor

Other Information

  • each piece contains: potassium 5 mg
  • contains milk and soy ingredients
  • gluten free
  • store at 15°-25°C (59°-77°F)

Inactive Ingredients

cocoa powder, hydrogenated vegetable oils (palm, palm kernel), salt, soy lecithin (an emulsifier), sugar, vanilla, and whey powder (milk)

Questions Or Comments?

1-855-423-2630

Principal Display Panel – 15 Mg Carton Label

NDC 83455-300-24

EQUALINE®

compare to
ex-lax®
active ingredient*

regular strength
chocolated stimulant
laxative

sennosides, USP, 15 mg

for gentle, dependable,
overnight relief

24 pieces

chocolate flavored

Principal Display Panel – 15 mg Carton Label (Equ02 0001 01)

Principal Display Panel – 15 mg Carton Label (Equ02 0001 01)

* Please review the disclaimer below.