Pleo Alkala Antacid
FDA Label NDC 60681-6001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sanum Kehlbeck Gmbh & Co. Kg for the product Pleo Alkala Antacid (NDC 60681-6001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding uses, ask a doctor or pharmacist before use, stop use and ask a doctor, tamper evident, directions, other information, inactive ingredients, principal display panel - 150 g carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

Relieves:

  • Heartburn
  • Sour stomach
  • Acid indigestion
  • Upset stomach associated with these symptoms

Ask A Doctor Or Pharmacist Before Use

  • if you have kidney disease or are on a sodium-restricted diet.
  • if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
  • if you are pregnant or nursing a baby.

Stop Use And Ask A Doctor

  • if symptoms or maximum dosage lasts more than 2 weeks.
  • may have laxative effect or cause constipation in some users.

Tamper Evident

This container has been designed for your safety to ensure product freshness. Do not use after expiration date. Do not use if the seal between the cap and container is broken or missing or imprinted security strip on carton is torn.

Directions

  • Use enclosed spoon. Take one spoonful in the morning with a glass of water. If needed, take a second spoonful in the evening, or as directed by a doctor.
  • Do not take more than 2 spoonfuls in a 24-hour period. If you are over 60 years old, do not take more than 1 spoonful. Not for children under 12 years.
  • Do not take maximum dose for more than 2 weeks.

Other Information

  • Do not use after expiration date.
  • Store at room temperature. Protect from heat and light.
  • Sodium per spoonful 1500 mg.
  • Potassium per spoonful 190 mg.

Inactive Ingredients

calcium lactate, sea salt, silica, sodium sulfate

Principal Display Panel - 150 G Carton

"The Original"
Pleo™ Alkala
Antacid
Powder

5.3 oz
(150 g)

Principal Display Panel (150 g Carton)

Principal Display Panel (150 g Carton)

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