Active Ingredient (In Each Chewable Tablet)
Acetaminophen 160 mg
Diphenhydramine HCI 12.5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Welly Health Pbc for the product Welly Childrens Travel Medicine (NDC 72663-203). 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 active ingredient (in each chewable tablet), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg
Diphenhydramine HCI 12.5 mg
Pain Reliever/ Fever Reducer
Antacid
Antihistamine
for the relief of
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
your child has liver disease.
your child is taking the blood thinning drug warfarin.
These could be signs of a serious condition
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.
In case of overdose, get medical help or contact a Poison Control Center right away.
| Weight (lb) | Age (yr) | Dose (chewable tablets)* |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 1 tablet |
| 36-47 | 4-5 | 1 1/2 tablets |
| 48-59 | 6-8 | 2 tablets |
| 60-71 | 9-10 | 2 1/2 tablets |
| 72-95 | 11 | 3 tablets |
*or as directed by a doctor
| Adults and children 12 years of age and over | 2 to 4 chewable tablets (25 to 50 mg) |
| Children 6 to under 12 years of age | 1 to 2 chewable tablets (12.5 to 25 mg) |
| Children under 6 years of age | Consult a doctor |
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose
acacia, cornstarch, D&C red# 27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, silicon dioxide, sodium lauryl sulfate, sucrose, talc
D&C Red #27 Aluminum Lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C Blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose
1-833-BE-WELLY (1-833-239-3559)
1-833-BE-WELLY (1-833-239-3559)
1-833-BE-WELLY (1-833-239-3559)
Calcium carbonate 400 mg
presently taking a prescription drug. Antacids may interact with certain prescription drugs.
taking sedatives or tranquilizers.
| Weight (lb) | Age (yr) | Dose (chewable tablets)* |
| under 24 | under 2 | ask a doctor |
| 24-47 | 2-5 | 1 tablet |
| 48-95 | 6-11 | 2 tablets |
*or as directed by a doctor
temporarily relieves runny nose and relieves sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.
ask a health professional before use.
* Please review the disclaimer below.