DoloDent Toothache

Acetaminophen, Caffeine · Tablet · Oral

Over the counter Central Nervous System Stimulant Methylxanthine

Active ingredient

Active ingredients and Purposes Active ingredients Purposes Acetaminophen 500 mg................... Pain reliever/fever reducer Caffeine 65 mg................................. Pain reliever aid

Purpose

Active ingredients Purposes Acetaminophen 500 mg................... Pain reliever/fever reducer Caffeine 65 mg................................. Pain reliever aid

Uses

Uses For the temporary relief of minor aches and pains due to: toothache headache and to reduce fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours , which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. Caffeine: 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 with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if allergic to any of the ingredients in this product on children under 12 years of age Ask a doctor before use if you have liver disease Ask a doctor before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor or dentist if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear If pregnant or breastfeeding, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. OVERDOSE WARNING: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not use

Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if allergic to any of the ingredients in this product on children under 12 years of age

Ask a doctor before use

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist

Ask a doctor before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor

Stop use and ask a doctor or dentist if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear

Pregnancy or breast-feeding

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN. OVERDOSE WARNING: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center 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

Directions do not take more than directed (see OVERDOSE WARNING) adults and children 12 years of age and older: take 2 tablets, every 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours children under 12 years of age: do not use

Other information

Other information store between 68°-77°F (20°-25°C)

Inactive ingredients

Inactive ingredients croscarmellose sodium, microcrystalline cellulose 101, povidone k30, silicon dioxide, stearic acid, water

Questions?

Questions? +1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Label text from the FDA structured product label by Pharmadel LLC (revised Sep 19, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

DoloDent Toothache NDC products (1)

NDCStrength & formLabelerType
55758-435Caffeine 65 mg/1; Acetaminophen 500 mg/1
Tablet
Pharmadel LLCOTC MONOGRAPH DRUG

Frequently asked questions

What is DoloDent Toothache used for?

Uses For the temporary relief of minor aches and pains due to: toothache headache and to reduce fever

Who makes DoloDent Toothache?

DoloDent Toothache is listed by 1 labeler in the FDA NDC directory, including Pharmadel LLC.