ONELAX SENNA- senna syrup

OneLAX SENNA by

Drug Labeling and Warnings

OneLAX SENNA by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP., UNIT DOSE SOLUTION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active ingredient (in each teaspoonful)         Purpose
Sennosides 8.8 mg …………………………................Laxative

Uses

relieves occasional constipation (irregularity), generally causes bowel movement in 6 to 12 hours

Warnings

ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel movements that continues over a period of 2 weeks

Do not use laxative products for longer than 1 week unless directed by a doctor

Ask a doctor or pharmacist before use if

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

Stop use and ask a doctor if

you have rectal bleeding or fail to have bowel movement after use of laxative. This may indicate 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.

Directions

take preferably at bedtime or as directed by a doctor. Shake Well Before Using.

DOSAGE & ADMINISTRATION

age	starting dose	maximum dosage
Adults and children 12 yeart and older	2-3 teaspoons once a day	3 teaspoons twice a day
Children 6 years to under 12 yeart	1 - 1 1/2 teaspoons once a day	11/2 teaspoons twice a day
Children 2 years to under 6 yeart	l/2 - 3/4 teaspoon once a day	3/4 teaspoon twice a day
Children under 2 years	ask a doctor	ask a doctor

Other Information

• Avoid accessive heat. Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

flavor choclate, mythylparaben, propylene glycol, propylparaben, purified water and sucrose

KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center immediately

Questions?

To Report Adverse Drug Event Call 1(877) 225-6999

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONELAX SENNA 
senna syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-1127(NDC:71399-0027)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	417.12 mg  in 237 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHOCOLATE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-1127-1	120 in 1 BOX, UNIT-DOSE	03/05/2024
1	NDC: 17856-1127-5	2.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 17856-1127-2	72 in 1 BOX, UNIT-DOSE	03/05/2024
2	NDC: 17856-1127-6	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3	NDC: 17856-1127-3	72 in 1 BOX, UNIT-DOSE	03/05/2024
3	NDC: 17856-1127-7	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4	NDC: 17856-1127-4	72 in 1 BOX, UNIT-DOSE	03/05/2024
4	NDC: 17856-1127-8	15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	02/06/2024

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
UNIT DOSE SOLUTION		360804194	repack(17856-1127)