Ascomp with Codeine

Name: Ascomp with Codeine

How should I take this medicine?

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your headaches.

Butalbital and codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away aspirin, butalbital, caffeine, and codeine is against the law.

If you need surgery or medical tests, tell the surgeon ahead of time that you are using this medicine.

Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop the medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. Butalbital and codeine are drugs of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What are some other side effects of Ascomp with Codeine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Hard stools (constipation).
  • Dizziness.
  • Feeling sleepy.
  • Headache.
  • Upset stomach or throwing up.
  • Feeling tired or weak.
  • Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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Ascomp with Codeine

NDC 0722-6094-01

Bottle Label x 100 Capsules

Ascomp with Codeine 
butalbital, aspirin, cafeine, and codeine phosphate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0722-6094
Route of Administration ORAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTALBITAL (BUTALBITAL) BUTALBITAL 50 mg
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
CAFFEINE (CAFFEINE) CAFFEINE 40 mg
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg
Product Characteristics
Color YELLOW (Yellow Body) , BLUE (Blue Cap) Score no score
Shape CAPSULE (Hard Gelatin Capsule) Size 14mm
Flavor Imprint Code B;074
Contains     
Packaging
# Item Code Package Description
1 NDC:0722-6094-01 100 CAPSULE in 1 BOTTLE
2 NDC:0722-6094-05 500 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075231 11/30/2001
Labeler - Nexgen Pharma, Inc. (048488621)
Registrant - Nexgen Pharma, Inc. (048488621)
Establishment
Name Address ID/FEI Operations
Nexgen Pharma, Inc. 160356114 MANUFACTURE(0722-6094), ANALYSIS(0722-6094), PACK(0722-6094), LABEL(0722-6094)
Revised: 12/2015   Nexgen Pharma, Inc.
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