Indications and uses
temporarily relieves minor aches and pains due to: a cold headache arthritis muscular aches toothache premenstrual and menstrual cramps
ANA-DENT
- Manufacturer
- Belmora LLC | LNK International, Inc.
- Effective date
- 2021-08-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:38:28
Label at a glance#
ProductANA-DENT
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure9 sections
Dosage and administration
do not take more than directed drink a full glass of water with each dose adults and children 12 years and over take 2 gelcaps every 6 hours do not take more than 8 gelcaps in 24 hours children under 12 years: ask a doctor
Storage and handling
avoid high humidity see end flap for expiration date and lot number store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Contacts and useful links#
Websitewww.anadentusa.com
www.anadentusa.com
www.anadentusa.comLabel contents#
Full prescribing information#
Active ingredients (in each gelcap)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Pain reliever
Pain reliever aid
Uses
- temporarily relieves minor aches and pains due to:
- a cold
- headache
- arthritis
- muscular aches
- toothache
- premenstrual and menstrual cramps
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:
- shock
- facial swelling
- hives
- asthma (wheezing)
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- have had stomach ulcers or bleeding problems
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
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 heartbeat.
Do not use
- if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have liver disease
- you have asthma
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug or are under a doctor’s care for any serious condition
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
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over
- take 2 gelcaps every 6 hours
- do not take more than 8 gelcaps in 24 hours
- children under 12 years: ask a doctor
Other information
- avoid high humidity
- see end flap for expiration date and lot number
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive ingredients
corn starch, D&C yellow #10, FD&C blue #1, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, simethicone, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?
Call 1-888-779-2877 M-F 9AM-5PM EST
Principal display panel
Belmora LLC
NDC 27854-175-01
ANA-DENT
Extra Strength
Headache Relief
24 Gelcaps
Actual Size
Ingredients for strong relief!
Acetaminophen 250 mg
Aspirin (NSAID) 250 mg
Caffeine 65 mg
Pain Reliever
Pain Reliever Aid
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by Belmora LLC, 2211 Crystal Dr.,
Suite 400, Arlington, VA 22202
www.anadentusa.com
Products#
Every source-derived product name is available through these pages.
- ANA-DENT
- Acetaminophen, Aspirin, Caffeine
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
- STARCH, CORN
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 6
- GELATIN, UNSPECIFIED
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- SHELLAC
- SODIUM LAURYL SULFATE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 27854-175 | 27854-175-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4e389534-b2c2-4181-9f84-9dd21db4c318 | 5c8d75de-19a5-4e6f-8023-8badea628826 | 2022-04-13 | Warnings | 5c8d75de-19a5-4e6f-8023-8badea628826 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.