DOLODENT TOOTHACHE FOR ADULTS- acetaminophen, caffeine tablet

DoloDent Toothache by

Drug Labeling and Warnings

DoloDent Toothache by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active ingredients and Purposes

• 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

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.

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

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

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

DOLODENT TOOTHACHE  FOR ADULTS
acetaminophen, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-435
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONE K30 (UNII: U725QWY32X)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE ((Capsule-Shaped Tablet))	Size	18mm
Flavor		Imprint Code	A2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-435-24	1 in 1 CARTON	07/30/2024
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/30/2024

Labeler - Pharmadel LLC (030129680)