Label: EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE- sennosides pill
- NDC Code(s): 0067-0016-24, 0067-0016-48, 0067-0016-90
- Packager: Novartis Consumer Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient
Sennosides, USP, 25 mgClose
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 12 hours
Do Not Use
Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
Ask 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.
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.
Keep Out of Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- swallow pill(s) with a glass of water
- swallow pill(s) whole, do not crush, break or chew
adults and children 12 years of age and older
2 pills once or twice daily
children 6 to under 12 years of age
1 pill once or twice daily
children under 6 years of age
ask a doctor
- Other information
- each pill contains: calcium 50 mg
- sodium free
- store at controlled room temperature 20-25C (68-77F). Protect from moisture.
- Inactive ingredients
acacia, alginic acid, carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, FD&C blue no.1 aluminum lake, iron oxide black, magnesium stearate, microcrystalline cellulose, potassium hydroxide, povidone, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxideClose
- Additional information listed on other panels
The Ex•Lax® Guarantee: When taken as directed, Ex•Lax® is guaranteed to work gently and effectively overnight or your money back. Return product to Novartis, attention Consumer Affairs, for full refund.
Tamper Evident Feature: Ex•Lax® Pills are sealed in blister packets. Use only if the individual seal is unbroken.
Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622 ©20xxClose
- Package/Label Principal Display Panel
SENNOSIDES, USP, 25 mg
RELIEF GUARANTEED EVERY TIME
GENTLE OVERNIGHT RELIEF YOU CAN TRUSTClose
- INGREDIENTS AND APPEARANCE
EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0067-0016 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (SENNOSIDES) SENNOSIDES 25 mg Inactive Ingredients Ingredient Name Strength ACACIA ALGINIC ACID CARNAUBA WAX SILICON DIOXIDE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C BLUE NO. 1 FERROSOFERRIC OXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POTASSIUM HYDROXIDE POVIDONE PROPYLENE GLYCOL SHELLAC SODIUM BENZOATE SODIUM LAURYL SULFATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE Product Characteristics Color BLUE Score no score Shape ROUND Size 11mm Flavor Imprint Code ex;lax;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-0016-24 2 in 1 CARTON 1 12 in 1 BLISTER PACK 2 NDC:0067-0016-90 6 in 1 CARTON 2 15 in 1 BLISTER PACK 3 NDC:0067-0016-48 4 in 1 CARTON 3 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2012 Labeler - Novartis Consumer Health, Inc. (879821635)