Metamucil ®

Metamucil ®
SPL v23
SPL
SPL Set ID a9824f73-5ea2-4a65-a926-3a57561441b8
Route
ORAL
Published
Effective Date 2024-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Psyllium Husk (3.4 g)
Inactive Ingredients
Citric Acid Monohydrate Aspartame Fd&c Yellow No. 6 Maltodextrin

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 1994-12-15

Description

Drug Facts

Purpose

Fiber laxative


Medication Information

Purpose

Fiber laxative

Description

Drug Facts

Uses
  • for relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.
Section 34088-5

In case of overdose, contact a doctor or a Poison Control Center right away.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Directions

Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. For a lighter flavor experience and thinner drink, use more water.

Adults 12 yrs. & older

1 packet in 8 oz of liquid at the first sign of irregularity.

Can be taken up to 3 times daily.

6 – 11 yrs. 1/2 packet in 8 oz of liquid, up to 3 times daily
Under 6 yrs. Consult a doctor

As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

New Users:Start with 1 dose per day; gradually increase to 3 doses per day as necessary.

Questions?

1-800-983-4237

• Choking:

Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Allergy Alert:

This product may cause allergic reactions in people sensitive to inhaled or ingested psyllium.

Other Information
  • each packet (5.8 g) contains:potassium 30 mg; sodium 5 mg
  • PHENYLKETONURICS: CONTAINS PHENYLALANINE,25 mg per packet
  • Store below 86º F (30º C)
Inactive Ingredients

aspartame, citric acid, FD&C Yellow No. 6, maltodextrin, natural and artificial orange flavor

Ask A Doctor Before Use

• abdominal pain, nausea or vomiting

• a sudden change in bowel habits persisting for 2 weeks

Principal Display Panel

MetaMUCIL

PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY

on-the-go!

30 packets

4-in-1 FIBER

HELPS SUPPORT:

Appetite Control*

Heart Health by Lowering Cholesterol†

Healthy Blood Sugar Levels*

Digestive Health *

SUGAR-FREE

not a low calorie food

†See back for information about soluble fiber and heart disease





ORANGE naturally and artificially flavored

30-0.21 OZ (5.8 g) POWDER PACKETS/NET WT 6.1 OZ (174g)

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Stop Use and Ask A Doctor

• constipation lasts more than 7 days

• rectal bleeding occurs

• you fail to have a bowel movement

These may be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Packet (5.8 G))

Psyllium husk approximately 3.4 g

Ask A Doctor Or Pharmacist Before Use If You

are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.


Structured Label Content

Uses
  • for relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.
Section 34088-5 (34088-5)

In case of overdose, contact a doctor or a Poison Control Center right away.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Fiber laxative

Directions

Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. For a lighter flavor experience and thinner drink, use more water.

Adults 12 yrs. & older

1 packet in 8 oz of liquid at the first sign of irregularity.

Can be taken up to 3 times daily.

6 – 11 yrs. 1/2 packet in 8 oz of liquid, up to 3 times daily
Under 6 yrs. Consult a doctor

As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

New Users:Start with 1 dose per day; gradually increase to 3 doses per day as necessary.

Questions?

1-800-983-4237

• Choking:

Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Allergy Alert: (ALLERGY ALERT:)

This product may cause allergic reactions in people sensitive to inhaled or ingested psyllium.

Other Information (Other information)
  • each packet (5.8 g) contains:potassium 30 mg; sodium 5 mg
  • PHENYLKETONURICS: CONTAINS PHENYLALANINE,25 mg per packet
  • Store below 86º F (30º C)
Inactive Ingredients (Inactive ingredients)

aspartame, citric acid, FD&C Yellow No. 6, maltodextrin, natural and artificial orange flavor

Ask A Doctor Before Use (Ask a doctor before use)

• abdominal pain, nausea or vomiting

• a sudden change in bowel habits persisting for 2 weeks

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MetaMUCIL

PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY

on-the-go!

30 packets

4-in-1 FIBER

HELPS SUPPORT:

Appetite Control*

Heart Health by Lowering Cholesterol†

Healthy Blood Sugar Levels*

Digestive Health *

SUGAR-FREE

not a low calorie food

†See back for information about soluble fiber and heart disease





ORANGE naturally and artificially flavored

30-0.21 OZ (5.8 g) POWDER PACKETS/NET WT 6.1 OZ (174g)

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

• constipation lasts more than 7 days

• rectal bleeding occurs

• you fail to have a bowel movement

These may be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Packet (5.8 G)) (Active ingredient (in each PACKET (5.8 g)))

Psyllium husk approximately 3.4 g

Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)

are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.


Advanced Ingredient Data


Raw Label Data

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