Acid Controller Original Strength

Name: Acid Controller Original Strength

Purpose

Acid reducer

Uses

  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Inactive ingredients

carnauba wax, hypromellose, iron oxides, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polydextrose, polyethylene glycol, talc, titanium dioxide, triacetin

Principal Display Panel

Compare to Original Strength Pepcid® AC active ingredient

Original Strength

Acid Controller

Famotidine Tablets, 10 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

Actual Size

Tablets

Acid Controller Carton

ACID CONTROLLER  ORIGINAL STRENGTH
famotidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0141
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8mm
Flavor Imprint Code L141
Contains     
Packaging
# Item Code Package Description
1 NDC:0363-0141-65 3 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 10 TABLET (TABLET) in 1 BLISTER PACK
2 NDC:0363-0141-75 1 BOTTLE (BOTTLE) in 1 CARTON
2 90 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075400 08/28/2009
Labeler - Walgreen Company (008965063)
Revised: 06/2009   Walgreen Company

Famotidine Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: B1 US FDA pregnancy category: B

Animal models have failed to reveal evidence of teratogenicity or changes in fertility. This drug crosses the placenta. Sporadic abortions occurred in an animal model at maternotoxic doses. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Famotidine Levels and Effects while Breastfeeding

Summary of Use during Lactation

Famotidine is used in newborn infants in higher dosages than are transmitted in breastmilk.[1] Famotidine would not be expected to cause any adverse effects in breastfed infants. No special precautions are required.

Drug Levels

Maternal Levels. Eight women who had "recently given birth" (not defined, but apparently within a few days postpartum) were given famotidine 40 mg orally. An average peak breastmilk level of 72 mcg/L occurred 6 hours after the dose.[2] Using the peak milk level data from this study, an exclusively breastfed infant would receive an estimated maximum of 0.01 mg/kg daily with this maternal dosage regimen or less than 2% of the maternal weight-adjusted dosage.

Seven women were given oral famotidine 40 mg daily in 2 or 4 divided doses for 3 days at 12 to 16 weeks postpartum. Average concentrations of famotidine in breastmilk were 53 and 55 mcg/L at 3 and 6 hours after a dose, respectively.[3]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Histamine H2-receptor blockade is known to stimulate prolactin secretion.[4] Oral famotidine usually does not affect serum prolactin levels, but rare cases of hyperprolactinemia and galactorrhea have been reported.[5][6] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternate Drugs to Consider

Cimetidine, Nizatidine, Omeprazole, Pantoprazole, Ranitidine, Sucralfate

References

1. Orenstein SR, Shalaby TM, Devandry SN et al. Famotidine for infant gastro-oesophageal reflux: A multi-centre, randomized, placebo-controlled, withdrawal trial. Aliment Pharmacol Ther. 2003;17(9):1097-107. PMID: 12752346

2. Courtney TP, Shaw RW, Cedar E et al. Excretion of famotidine in breast milk. Br J Clin Pharmacol. 1988;26:639P. Abstract. PMC: PMC1386642

3. Wang X, Zhan Y, Hankins GD et al. Pharmacokinetics of famotidine in pregnant women. Am J Obstet Gynecol. 2011;204:S72-3. Abstract.

4. Knigge UP. Histaminergic regulation of prolactin secretion. Dan Med Bull. 1990;37:109-24. PMID: 2188799

5. Delpre G, Lapidot M, Lipchitz A et al. Hyperprolactinaemia during famotidine therapy. Lancet. 1993;342:868. Letter. PMID: 8104296

6. Guven K, Kelestimur F. Hyperprolactinemia and galactorrhea with standard-dose famotidine therapy. Ann Pharmacother. 1995;29:788. Letter. PMID: 8520102

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