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  5. Label Information: Leader Regular Strength Chocolate Laxative Sennosides

FDA Label for Leader Regular Strength Chocolate Laxative Sennosides

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH PIECE)
    2. PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR
    6. OTC - ASK DOCTOR/PHARMACIST
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL – CHOCOLATED LAXATIVE CARTON LABEL

Leader Regular Strength Chocolate Laxative Sennosides Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Piece)



Sennosides, 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


Otc - Ask Doctor



Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks


Otc - Ask Doctor/Pharmacist



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.


Otc - When Using



When using this product do not use for a period longer than 1 week


Otc - Stop Use



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 olderchew 2 chocolated pieces once or twice daily
children 6 to under 12 years of agechew 1 chocolated piece once or twice daily
children under 6 years of ageask a doctor

Other Information



  • each piece contains: potassium 10 mg
  • 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?



1-877-586-7979


Principal Display Panel – Chocolated Laxative Carton Label



LEADER™

NDC 70000-0477-1

Regular Strength

Chocolated
Laxative

Sennosides, USP, 15 mg | Stimulant Laxative

Chocolate
Flavored

Relieves Occasional
Constipation

24 pieces

Actual Size

COMPARE TO
ex•lax®
REGULAR
STRENGTH
active ingredient*

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* Please review the disclaimer below.