NAME OF THE PRODUCT & STRENGTHS

S. No REQUIRED INFORMATION RESPONSE

Dried Aluminum Hydroxide IP,
1. a. Name of the Drugs Magnesium Hydroxide IP,
Simethicone
Dried Aluminum Hydroxide IP - Class IV
b. Class of the Drugs Magnesium Hydroxide IP – Class IV
Simethicone – Class II
This medication is used to treat the symptoms
of too much stomach acid such as stomach
upset, heartburn, and acid indigestion. It is
also used to relieve symptoms of extra gas
c. Indication of the Drugs
such as belching, bloating, and feelings of
pressure/discomfort in the stomach/gut.
Simethicone helps break up gas bubbles in the
gut.
Dosage & strength of the Formulation
1. Dosage Suspension
d. Dried Aluminum Hydroxide IP 250mg,
Magnesium Hydroxide IP 250mg,
2. Strengths
Simethicone Emulsion (30%) USP equivalent
to Simethicone 50mg
e. Route of administration Oral
Each 5mL contains Dried Aluminum
Hydroxide IP 250mg, Magnesium Hydroxide
f. Composition of the Product
IP 250mg, Simethicone Emulsion (30%) USP
equivalent to Simethicone 50mg
Status of drug whether approved/
g. Approved product
unapproved new drug
2. Flow chart of Manufacturing Process Flow chart shown below
Details of raw materials used in the
3. Details given below
manufacturing process
Details of the tests which to be
4. performed with the drug (list of Method of analysis is attached
standard testing procedures)
5. Monographs Attached
6. Label Artwork Label artwork given below

2. Flow Chart
Step 1: Simple Sugar Preparation
Add Purified Water, Sugar, MPS ,PPS & EDTA,
Citric acid, Sodium Benzoate, Heat at 800c.

Step 2: Mixing (Homogenization)

Add Cetirizine HCL, Sorbitol 70%, Colour, Flavour
 filter thro’ # 200 to Manufacturing Tank.

In-process Check By IPQA

(Analysis of Bulk Sample)

Filling of Approved Bulk Solution

(Bottle filling)

Bottle Capping

Visual Inspection

Labeling and Coding

Finished product Analysis

Release to FG Store after approval by QA

3. Excipients used and its Use.

S.NO INGREDIENTS Label claim Use

1 Dried Alu. Hydr. Paste 250 API
2 Mg. Hydroxide Paste 250 API
3 Simethicone 50 API
4 Sorbitol Solution 70% 1.25 Syrup base
5 Guar Gum 0.18 Suspending agent
6 Bronopol 0.01 Preservative
7 Methyl Paraben 0.05 Preservative
8 Propyl Paraben 0.75 Preservative
9 Menthol 0.08 Flavour
10 Benzoic Acid 0.27 Preservative
11 Colour 0.018 Coloring agent
12 Aspartame 0.02 Syrup base

4. Method of Analysis: Attached

5. Monographs: Attached
6. Label Artwork: