Drug Facts
Drug Facts
Dolodent Toothache Tablet
FDA Label NDC 55758-435
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Dolodent Toothache (NDC 55758-435). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor before use if you are, stop use and ask a doctor or dentist if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purposes |
| Acetaminophen 500 mg................... | Pain reliever/fever reducer |
| Caffeine 65 mg................................. | Pain reliever aid |
Uses
For the temporary relief of minor aches and pains due to:
- toothache
- headache
- and to reduce fever
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
- skin reddening
- blisters
- rash. If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
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
- store between 68°-77°F (20°-25°C)
Inactive Ingredients
corn starch, microcrystalline cellulose 112, povidone k30, silicon dioxide, sodium starch glycolate type A corn, stearic acid
Questions?
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Distributed By / Distribuido Por:
PHARMADEL LLC
New Castle, DE, 19720
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