Solimo 831.000_831AA Mineral Oil

Mineral oil by

Drug Labeling and Warnings

Mineral oil by is a Otc medication manufactured, distributed, or labeled by Amazon.Com Services LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINERAL OIL- mineral oil oil 
Amazon.Com Services LLC

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Solimo 831.000_831AA
Mineral Oil

Active ingredient

Mineral oil 99.9%

Purpose

Lubricant laxative

Use

for relief of occasional constipation (irregularity).  Generally productes bowel movement in 6 to 8 hours.

Warnings

Do not use

• if you have difficulty swallowing
• in children under 6 years of age
• if you are pregnant
• for a period of longer than 1 week
• if you are bedridden or aged

Ask a doctor before use if you have 

• abdominal pain, nausea, or vomiting
• 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 

• presently taking a stool softener laxative
• taking any other drug.  Take this product 2 or more hours before or after other drugs.
• Laxatives may affect how other drugs work.

When using this product 

do not take with meals.  Take only at bedtime.

Stop use and ask a doctor

if you have rectal bleeding or failure to have a bowel movement after use.  These could be signd of serious condition.

If 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

• do not take with meals
• take only at bedtime
• may be taken as a single daily dose or in divided doses

adults and children 12 years of age and over - 1 to 3 Tablespoons (15 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to 12 years of age - 1 to 3 teaspoons (15 mL) in 24 hours

children under 6 years of age - do not use, consult a doctor

Other information

keep tightly closed.  Protect from sunlight.

Inactive ingredients

mixed tocopherols (added as a stabilizer)

DISTRIBUTED BY:

Amazon.com, Services, Inc

Seattle, WA 98109

1-877-485-0385

2018 Amazon.com, Inc. or its afiliated.

All rights reserved. Solimo and all related logos are are trademarks of

Amazon.com, Inc or its affiliates.

831.000/831AA

principal display panel

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION.

SOLIMO

MINERAL OIL U.S.P.

LUBRICANT LAXATIVE

Odorless tasteless colorless

16 FL OZ (1 PT) 473 mL

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-831
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-831-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2018	12/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	05/01/2018	12/30/2022

Labeler - Amazon.Com Services LLC (128990418)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(72288-831)

Revised: 9/2024

Document Id: 21f1a898-0664-f07e-e063-6294a90a4a1d

34390-5

Set id: 431225c5-a2a4-47e2-a6e9-4248eb80f9fd

Version: 4

Effective Time: 20240912