Indication:
U.S. FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
213. Paracetamol 30-09-08
+ Meloxicam
+ Benzyl Alcohol
+Lignocaine (5mg/ml+ 150mg/ml + 1%+1%)
Injection
Indicated for the treatment of mastitis,metritis,
pneumonia, pleuritis, fever and relieving of
acute pain in musculoskeletal disorders in
animals
265. Paracetamol solution for Infusion 10mg/ml 23-12-08
For short term treatment of moderate pain, especially
following surgery and for the short term treatment of
fever, when administered by I.V route is clinically
justified
268. Paracetamol 24-12-08
+Phenylephrine Hcl
(Each 6gm sachet contains: 500mg+ 10mg)
Sachet
For the treatment of fever associated with cold,nasal
congestion in adults
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Paracetamol +Meloxicam 30-09-2008
+ Benzyl alcohol + Lignocaine
(5mg/ml 150mg/ml +1% +1%)
Injection
Indicated for the Treatment of Mastitis, Metritis,Pneumonia ,Pleuritis,
Fever and relieving of acute pain in /musculoskeletal disorders in
animals
2.Paracetamol +Phenylephrine Hcl 24-12-2008
(Each 6gm sachet contains 500mg +10mg)
sachet
For the treatment of fever associated with cold, nasal congestion
in adults
3.Paracetamol 325mg +Tramadol Hcl 21-06-2011
37.5mg tablets
Additional Indication (for symptomatic treatment of moderate to
severe pain
4.Paracetamol 500mg/500mg 21-09-2010
+ Thioclchicoside 4mg/8mg
Tablet
For the treatment of acute inflammation conditions associated
with spasm in adults only
5.Paracetamol Chewable Tablet 05-01-2011
500mg (Addl.Dosage Form)
Same as approved
6.Paracetamol Fast release Tablet 10-02-2011
500mg (Addl.Dosage Form)
Same as approved
7.Paracetamol IP 500mg 13-10-2010
+ Phenylephrine hcl IP 5mg
+ Caffeine (Anhydrous) IP 30mg
+ Diphenhydramine hcl IP 25mg tablet
For the treatment of Fever associated with Cold,Nasal congestion in
Adults
8.Paracetamol Solution For Infusion 10-02-2010
(10mg/ml ) in 50ml
( Addl.Pack size)
Same as approved
9.Paracetamol Solution For Infusion 23-12-2008
10mg/ml
For the Short term treatment of moderate pain, especially
following surgery and for the short term treatment of fever
when administration by IV route is clinically justified
10.Paracetamol SR 1000mg 24-05-2010
Bilayered tablet
For symptomatic treatment of pain and fever
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1. Paracetamol 120mg + May 1976
Di phenylpyramine HCL 1.5mg +
Phenylpropranolamine HCL 10mg per ml
expotorant
2.Paracetamol 300mg + Dec 1972
D-propoxyphene HCL 25mg per tablet
3. Paracetamol 450mg + Oct 1982
Chlormezanone 100mg tablet
4. Paracetamol IP 325mg + 07-12-2011
Parabrom USP 25mg tablet
For the treatment of fever associated with cold,
nasal congetion in adults
5.Phenyl dimethyl isopropyl pyrazolone 150mg+ Nov 1980
Diethyl dioxotetrahydro pyridine 50mg +
Paracetamol 250mg +
Caffeine anhydrous46.75mg
Moderate to severe pain
INFORMATION -UPDATE
US- PARACETAMOL DOSE REDUCED IN FDCs
The United States Food and Drug Administration (USFDA) has ordered the reduction of
paracetamol to 325mg per dose for adults in Fixed-Dose Combination (FDCs) products
to reduce liver toxicity.
Paracetamol is permitted to be combined with aspirin and opiods ( codeine, pentazocaine
and tramadol ) only in the United States
The action has been taken since both paracetamol and opiods cause liver injury. (MIMS).
Patient Information:
Acetoaminophen - commonly used names are APAP and Paracetamol
1. Allergies- Tell your doctor if ever you had any unusaual allergic reactions to
acetoaminophen or aspirin. Also tell, your doctor if you are allergic to any other substances
such as foods, preservatives or dyes.
2. Pregnancy - acetoaminophen has not been reported to cause birth defects or other
problems.
3. Breast feeding- it has not been reported to cause problems in nursing babies
4. Elderly- acetoaminophen has not shown to cause different side effects or problems
in older people than it does in younger adults.
5. Other medicines- certain other medicines should not be used together at all, in other
cases two different medicines may be used together even if interaction might occur.
Tell your doctor if you are taking any other prescription or non-prescription ( OTC )
medicines.
6. Other medical problems - presence of other medical problems may affect the use of
acetoaminophen . Make sure you tell your doctor if you have any other medical
problems -
Alchol abuse, Kidney disease,
Hepatitis or other liver disease - chance of serious side effects may be increased.
Phenylketonuria - some brands of acetoaminophen may contain aspartame, which
can make the condition worse.
7. Dosing- follow your doctors advice or directions given on the label. If your dose
is different do not change it unless your doctor tells you to do so
Manufacturer Details