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NDC 63736-0200-93 Anacin 400; 32 mg/1; mg/1 Details
Anacin 400; 32 mg/1; mg/1
Anacin is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Insight Pharmaceuticals LLC. The primary component is ASPIRIN; CAFFEINE.
Product Information
NDC | 63736-0200 |
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Product ID | 63736-200_11bd624d-b3d5-4ea4-ae24-705364eb2603 |
Associated GPIs | 64990002250310 |
GCN Sequence Number | 004319 |
GCN Sequence Number Description | aspirin/caffeine TABLET 400MG-32MG ORAL |
HIC3 | H3D |
HIC3 Description | ANALGESIC/ANTIPYRETICS, SALICYLATES |
GCN | 71221 |
HICL Sequence Number | 001794 |
HICL Sequence Number Description | ASPIRIN/CAFFEINE |
Brand/Generic | Brand |
Proprietary Name | Anacin |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Asprin and Caffeine |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 400; 32 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | ASPIRIN; CAFFEINE |
Labeler Name | Insight Pharmaceuticals LLC |
Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [E |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part343 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 63736-0200-93 (63736020093)
NDC Package Code | 63736-200-93 |
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Billing NDC | 63736020093 |
Package | 1 BOTTLE in 1 BOX (63736-200-93) / 300 TABLET in 1 BOTTLE |
Marketing Start Date | 2009-06-25 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 51ab0ee3-3c94-424d-a30a-2d6c14e3d8ff Details
SPL UNCLASSIFIED SECTION
Active ingredients (per tablet)
Uses
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert:
Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Stomach bleeding warning
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinner (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if
you are taking a prescription drug for diabetes, gout, or arthritis
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- feel faint
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
Caffeine warning
The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
Directions
-
do not use more than directed (see overdose warning)
- drink a full glass of water with each dose
- adults and children 12 years of age and older: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
- children under 12 years of age: do not use
Inactive ingredients
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ANACIN
asprin and caffeine tablet |
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Labeler - Insight Pharmaceuticals LLC (055665422) |