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Promethazine Hydrochloride tablets USP 25mg Promethazine Hydrochloride tablets USP 25mg Promethazine Hydrochloride tablets USP 25mg Promethazine Hydrochloride tablets USP 25mg Promethazine Hydrochloride tablets USP 25mg Promethazine Hydrochloride tablets USP 25mg Promethazine Hydrochloride tablets USP 25mg
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Promethazine Hydrochloride tablets USP 25mg Technical Specification:]

Product Name:Promethazine Hydrochloride tablets USP 25mg
Brand Name:Generic
Strength:(12.5mg), (25mg), (50mg)
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antiallergic, Antihistamine
Indication: Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times.
Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Promethazine Hydrochloride tablets USP 25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Promethazine Hydrochloride tablets USP 25mg
    Each Film-coated tablet contains:
    Promethazine Hydrochloride USP
    Equivalent to Promethazine………………..……………25mg
    Excipients…………………………………………………………..q.s
    Colour: Sunset yellow

THERAPEUTIC INDICATIONS:

Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.

Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Promethazine Hydrochloride tablets USP 12.5mg
B. Promethazine Hydrochloride tablets USP 25mg
C. Promethazine Hydrochloride tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Promethazine Hydrochloride tablets USP 12.5mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………12.5mg
Excipients…………………………………………………..……..q.s
Colour: Sunset yellow FCF

B. Promethazine Hydrochloride tablets USP 25mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………25mg
Excipients…………………………………………………………..q.s
Colour: Sunset yellow

C. Promethazine Hydrochloride tablets USP 50mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………50mg
Excipients…………………………………………………………..q.s
Colour: Sunset yellow lake

THERAPEUTIC INDICATIONS:

Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.