Indications and uses
for the temporary relief of minor aches and pains associated with the common cold sore throat headache toothache flu and to reduce fever
for the temporary relief of minor aches and pains associated with the common cold sore throat headache toothache flu and to reduce fever
this product does not contain directions or complete warnings for adult use do not give more than directed find the right dose on the chart below. If possible, use weight to dose; otherwise, use age. chew or crush tablets completely before swallowing; do not swallow tablets whole repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed...
Acetaminophen 160 mg
Pain Reliever/ Fever Reducer
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.
| 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
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
1-833-BE-WELLY (1-833-239-3559)
Calcium carbonate 400 mg
Antacid
for the relief of
presently taking a prescription drug. Antacids may interact with certain prescription drugs.
| 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
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
1-833-BE-WELLY (1-833-239-3559)
Diphenhydramine HCI 12.5 mg
Antihistamine
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.
taking sedatives or tranquilizers.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
| 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 |
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)
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 313820 | acetaminophen 160 MG Chewable Tablet | PSN | 2 |
| 317865 | calcium carbonate 400 MG (Ca 170 MG) Chewable Tablet | PSN | 2 |
| 1049900 | diphenhydrAMINE HCl 12.5 MG Chewable Tablet | PSN | 2 |
| 313820 | acetaminophen 160 MG Chewable Tablet | SCD | 2 |
| 317865 | calcium carbonate 400 MG Chewable Tablet | SCD | 2 |
| 1049900 | diphenhydramine hydrochloride 12.5 MG Chewable Tablet | SCD | 2 |
| 313820 | APAP 160 MG Chewable Tablet | SY | 2 |
| 317865 | calcium carbonate 400 MG (as calcium 161 MG) Chewable Tablet | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bee4fa8d-8d82-423a-a0b5-40a89dd13a99 | Product name | 1 | 20250618 |
| e0d2eb29-08bd-4bba-90d1-c91c68a38767 | Product name | 4 | 20250516 |
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 334fe8d2-68fb-4331-a576-420e302ec069 | Product name | 7 | 20240320 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| e92765c1-be81-432a-b909-1b10777ec378 | Product name | 1 | 20190208 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 0441a8f5-3835-497c-aedd-bc78cba56b2a | Product name | 1 | 20150317 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72663-203-49 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f0bf-a426-e053-dadaa90af4c2 | Welly Children's Travel Medicine Kit |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72663-203-49 | Welly Childrens Travel Medicine | 1 in 1 KIT | KIT | 1 | 2 | |
| 72663-233-49 | Welly Childrens Travel Medicine | 6 in 1 BLISTER PACK | TABLET, CHEWABLE | 12 | 160 mg | 2 |
| 72663-233-49 | Welly Childrens Travel Medicine | 2 in 1 KIT | TABLET, CHEWABLE | 160 mg | 2 | |
| 72663-347-49 | Welly Childrens Travel Medicine | 6 in 1 BLISTER PACK | TABLET, CHEWABLE | 12 | 12.5 mg | 2 |
| 72663-347-49 | Welly Childrens Travel Medicine | 2 in 1 KIT | TABLET, CHEWABLE | 12.5 mg | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72663-203 | WELLY CHILDRENS TRAVEL MEDICINE (ACETAMINOPHEN, CALCIUM CARBONATE, DIPHENHYDRAMINE HYDROCHLORIDE) KIT [WELLY HEALTH PBC] | 2 | Legacy NDC, 5 package rows | 20200423_ebe7a83b-8ee3-444a-a983-e5e1f0273e14.zip |
| 72663-225 | WELLY CHILDRENS TRAVEL MEDICINE (ACETAMINOPHEN, CALCIUM CARBONATE, DIPHENHYDRAMINE HYDROCHLORIDE) KIT [WELLY HEALTH PBC] | 2 | Unmatched | 20200423_ebe7a83b-8ee3-444a-a983-e5e1f0273e14.zip |
| 72663-233 | WELLY CHILDRENS TRAVEL MEDICINE (ACETAMINOPHEN, CALCIUM CARBONATE, DIPHENHYDRAMINE HYDROCHLORIDE) KIT [WELLY HEALTH PBC] | 2 | Unmatched | 20200423_ebe7a83b-8ee3-444a-a983-e5e1f0273e14.zip |
| 72663-347 | WELLY CHILDRENS TRAVEL MEDICINE (ACETAMINOPHEN, CALCIUM CARBONATE, DIPHENHYDRAMINE HYDROCHLORIDE) KIT [WELLY HEALTH PBC] | 2 | Unmatched | 20200423_ebe7a83b-8ee3-444a-a983-e5e1f0273e14.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 72663-203 | 72663-203-49 |
| 72663-233 | 72663-233-49 |
| 72663-225 | 72663-225-49 |
| 72663-347 | 72663-347-49 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a359ac07-b87f-2440-e053-2a95a90a4b16 | ebe7a83b-8ee3-444a-a983-e5e1f0273e14 | 2020-04-15 | Warnings | a359ac07-b87f-2440-e053-2a95a90a4b16 ebe7a83b-8ee3-444a-a983-e5e1f0273e14 |
Adverse event summaries are temporarily unavailable. Other product information remains available.