Welly Childrens Travel Medicine

Manufacturer
Welly Health PBC
Effective date
2020-04-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:07:33

Label at a glance#

ProductWelly Childrens Travel Medicine
Active ingredientACETAMINOPHEN, CALCIUM CARBONATE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure25 sections

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

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/ Fever Reducer

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of minor aches and pains associated with
  • the common cold
  • sore throat
  • headache
  • toothache
  • flu
  • and to reduce fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetominophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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.

Do not use

OTC - DO NOT USE SECTION

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

your child has liver disease.

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

your child is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain persists for more than 5 days or gets worse
  • fever persists for more than 3 days or gets worse.
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 by a doctor
 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

Other information

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • see label for expiration date and lot number
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-833-BE-WELLY (1-833-239-3559)

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 400 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

for the relief of

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

  • do not take more than 3 chewable tablets (ages 2-5) or 6 chewable tablets (ages 6-11) in a 24-hour period
  • do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • find the right dose on the chart on the next page based on weight (preferred); otherwise use age
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • repeat dose as needed, not more than 3 times a day
 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

Other information

SPL UNCLASSIFIED SECTION

  • Each chewable tablet contains: calcium 160 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • see label for expiration date and lot number
  • use by expiration date on package

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-833-BE-WELLY (1-833-239-3559)

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCI 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use

INDICATIONS & USAGE SECTION

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.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • may cause excitability in children
  • may cause marked drowsiness; alcohol, sedatives, and traquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • find right dose on the chart below
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
 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

Other information

SPL UNCLASSIFIED SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • see label for expiration date and lot number
  • use by expiration date on package

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-833-BE-WELLY (1-833-239-3559)

Package Labeling:(72663-203-49)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKit

Package Labeling:(72663-233-49)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:(72663-225-49)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:(72663-347-49)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313820acetaminophen 160 MG Chewable TabletPSN2
317865calcium carbonate 400 MG (Ca 170 MG) Chewable TabletPSN2
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSN2
313820acetaminophen 160 MG Chewable TabletSCD2
317865calcium carbonate 400 MG Chewable TabletSCD2
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCD2
313820APAP 160 MG Chewable TabletSY2
317865calcium carbonate 400 MG (as calcium 161 MG) Chewable TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72663-203-492022-01-28C16284748780-1d6a99b39-f0bf-a426-e053-dadaa90af4c2Welly Children's Travel Medicine Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72663-203-49Welly Childrens Travel Medicine1 in 1 KITKIT12
72663-233-49Welly Childrens Travel Medicine6 in 1 BLISTER PACKTABLET, CHEWABLE12160 mg2
72663-233-49Welly Childrens Travel Medicine2 in 1 KITTABLET, CHEWABLE160 mg2
72663-347-49Welly Childrens Travel Medicine6 in 1 BLISTER PACKTABLET, CHEWABLE1212.5 mg2
72663-347-49Welly Childrens Travel Medicine2 in 1 KITTABLET, CHEWABLE12.5 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72663-203WELLY CHILDRENS TRAVEL MEDICINE (ACETAMINOPHEN, CALCIUM CARBONATE, DIPHENHYDRAMINE HYDROCHLORIDE) KIT [WELLY HEALTH PBC]2Legacy NDC, 5 package rows20200423_ebe7a83b-8ee3-444a-a983-e5e1f0273e14.zip
72663-225WELLY CHILDRENS TRAVEL MEDICINE (ACETAMINOPHEN, CALCIUM CARBONATE, DIPHENHYDRAMINE HYDROCHLORIDE) KIT [WELLY HEALTH PBC]2Unmatched20200423_ebe7a83b-8ee3-444a-a983-e5e1f0273e14.zip
72663-233WELLY CHILDRENS TRAVEL MEDICINE (ACETAMINOPHEN, CALCIUM CARBONATE, DIPHENHYDRAMINE HYDROCHLORIDE) KIT [WELLY HEALTH PBC]2Unmatched20200423_ebe7a83b-8ee3-444a-a983-e5e1f0273e14.zip
72663-347WELLY CHILDRENS TRAVEL MEDICINE (ACETAMINOPHEN, CALCIUM CARBONATE, DIPHENHYDRAMINE HYDROCHLORIDE) KIT [WELLY HEALTH PBC]2Unmatched20200423_ebe7a83b-8ee3-444a-a983-e5e1f0273e14.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a359ac07-b87f-2440-e053-2a95a90a4b16ebe7a83b-8ee3-444a-a983-e5e1f0273e142020-04-15WarningsExact identifier
spl id: a359ac07-b87f-2440-e053-2a95a90a4b16
spl set id: ebe7a83b-8ee3-444a-a983-e5e1f0273e14

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.