Dolodent Toothache (v)

SPL v5

SPL

SPL Set ID 1e7a0c06-ad3c-b94f-e063-6394a90abab1

Route

ORAL

Published

Effective Date 2024-07-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Caffeine (65 mg) Acetaminophen (500 mg)

Inactive Ingredients

Croscarmellose Povidone K30 Microcrystalline Cellulose 101 Stearic Acid Silicon Dioxide Water

Identifiers & Packaging

Pill Appearance

Imprint: A2 Shape: capsule Color: white Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-07-30

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

For the temporary relief of minor aches and pains due to:

toothache
headache
and to reduce fever

Section 55105-1

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

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.

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

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

Drug Facts

Drug Facts

Questions?

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

Other Information

store between 68°-77°F (20°-25°C)

Inactive Ingredients

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

Principal Display Panel

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.

Distributed By / Distribuido Por:

PHARMADEL LLC

New Castle, DE, 19720

Ask A Doctor Before Use If You Are

taking the blood thinning drug warfarin

Ask A Doctor Before Use If You Have

liver disease

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

Structured Label Content

Uses

For the temporary relief of minor aches and pains due to:

toothache
headache
and to reduce fever

Section 55105-1 (55105-1)

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

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.

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

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

Drug Facts

Drug Facts

Questions?

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

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

Principal Display Panel

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

Distributed By / Distribuido Por: (Distributed by / Distribuido por:)

PHARMADEL LLC

New Castle, DE, 19720

Ask A Doctor Before Use If You Are (Ask a doctor before use if you are)

taking the blood thinning drug warfarin

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Stop Use and Ask A Doctor Or Dentist If (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

Advanced Ingredient Data

[{"name": "CROSCARMELLOSE", "unii": "029TFK992N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE 101", "unii": "7T9FYH5QMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAFFEINE", "unii": "3G6A5W338E", "classCode": "ACTIB", "strengthNumerator": "65", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of minor aches and pains due to: toothache headache and to reduce fever", "55105-1": "Active ingredients Purposes Acetaminophen 500 mg................... Pain reliever/fever reducer Caffeine 65 mg................................. Pain reliever aid", "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.", "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", "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", "Drug Facts": "Drug Facts", "Questions?": "+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com", "Other information": "store between 68°-77°F (20°-25°C)", "Inactive ingredients": "croscarmellose sodium, microcrystalline cellulose 101, povidone k30, silicon dioxide, stearic acid, water", "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.", "Distributed by / Distribuido por:": "PHARMADEL LLC New Castle, DE, 19720", "Ask a doctor before use if you are": "taking the blood thinning drug warfarin", "Ask a doctor before use if you have": "liver disease", "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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:36.559491 · Updated: 2026-03-14T23:03:46.018464