Welly Travel Medicine Kit

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 23:07:34

Label at a glance#

ProductWelly Travel Medicine Kit
Active ingredientMECLIZINE HYDROCHLORIDE, IBUPROFEN, DIMETHICONE, LOPERAMIDE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure41 sections

Indications and uses

temporarily relieves minor aches and pains due to: muscular aches backache toothache menstrual cramps headache the common cold minor pain of arthritis temporarily reduces fever

Dosage and administration

to prevent motion sickness, take the first dose ½ hour to 1 hour before starting activity to treat motion sickness, take at first signs of symptoms adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCI 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Use

INDICATIONS & USAGE SECTION

for the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

for children under 12 years of age unless directed by a doctor

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

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers 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

  • to prevent motion sickness, take the first dose ½ hour to 1 hour before starting activity
  • to treat motion sickness, take at first signs of symptoms
  • adults and children 12 years and over: 1 to 2 tablets once daily, 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)
  • protect from heat and humidity
  • see label for expiration date and lot number
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

Active ingredient (in each brown tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
  • muscular aches
  • backache
  • toothache
  • menstrual cramps
  • headache
  • the common cold
  • minor pain of arthritis
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • shock
  • facial swelling
  • asthma (wheezing)
  • rash
  • skin reddening
  • blisters
  • hives

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn.
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because uprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding.
  • Feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • slurred speech
  • leg swelling
  • trouble breathing
  • weakness in one part or side of body
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • If pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • TAMPER EVIDENT: DO NO USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat 40°C (104°F)
  • see label for expiration date and lot number
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-833-BE-WELLY

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

relieves bloating, pressure, and fullness commonly referred to as gas.

Warning

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • adults: take 1 or 2 chewable tablets as needed after meals and at bedtime
  • do not exceed 4 chewable tablets in 24 hours unless directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each chewable tablets contains: calcium 90 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)
  • protect from moisture
  • 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, FD&C red #40 aluminum lake, flavor, silicon dioxide, sorbitol, starch, stearic acid, talc, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

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

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCI 2 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI.
Heart alert: Taking more than directed can cause serious heart problems or death.

Do not use

OTC - DO NOT USE SECTION

you have bloody or black stool.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • A fever
  • Mucus in the stool
  • A history of liver disease
  • A history of abnormal heart rhythm

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

When using this product,

OTC - WHEN USING SECTION

tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms get worse
  • diarrhea lasts for more than 2 days
  • you get abdominal swelling or bulging.These may be signs of a serious condition.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
 adults and children 12 years and over  2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
 children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
 children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
 Children 2-5 years (34-47 lbs) ask a doctor
 Children under 2 years (up to 33 lbs) do not use

Other information

SPL UNCLASSIFIED SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20°-25°C (68°-77°F)
  • see label for expiration date and lot number
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide 

Questions or comments?

OTC - QUESTIONS SECTION

1-833-BE-WELLY

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Doxylamine succinate 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

helps to reduce difficulty in falling asleep

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before

OTC - ASK DOCTOR/PHARMACIST SECTION

use if you are taking any other drugs.

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages
  • take only at bedtime

Stop use and ask a doctor

OTC - STOP USE SECTION

if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • children under 12 years: do not use

Other information

SPL UNCLASSIFIED SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at controlled room temperature 20°-25°C (68-77°F)
  • see label for expiration date and lot number
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

1-833-BE-WELLY

Package Labeling:(72663-205-48)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kit2Kit2

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Package Labeling:(72663-428-48)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

Package Labeling:(72663-746-48)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label6Label6

Package Labeling:(72663-567-48)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label7Label7

Package Labeling:(72663-369-48)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label8Label8

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN2
310965ibuprofen 200 MG Oral TabletPSN2
978010loperamide HCl 2 MG Oral TabletPSN2
995666meclizine HCl 25 MG Oral TabletPSN2
314221simethicone 125 MG Chewable TabletPSN2
1101446doxylamine succinate 25 MG Oral TabletSCD2
310965ibuprofen 200 MG Oral TabletSCD2
978010loperamide hydrochloride 2 MG Oral TabletSCD2
995666meclizine hydrochloride 25 MG Oral TabletSCD2
314221simethicone 125 MG Chewable TabletSCD2
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
LOPERAMIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MECLIZINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72663-205-482022-01-28C16284748780-1d6a99b39-a36e-a426-e053-dadaa90af4c2Welly Travel Medicine Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72663-205-48Welly Travel Medicine Kit1 in 1 KITKIT12
72663-369-48Welly Travel Medicine Kit8 in 1 BLISTER PACKTABLET825 mg2
72663-428-48Welly Travel Medicine Kit16 in 1 BOTTLETABLET16200 mg2
72663-567-48Welly Travel Medicine Kit12 in 1 BLISTER PACKTABLET122 mg2
72663-632-48Welly Travel Medicine Kit8 in 1 BLISTER PACKTABLET825 mg2
72663-746-48Welly Travel Medicine Kit2 in 1 KITTABLET, CHEWABLE125 mg2
72663-746-48Welly Travel Medicine Kit6 in 1 BLISTER PACKTABLET, CHEWABLE12125 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72663-205WELLY TRAVEL MEDICINE KIT (MECLIZINE HYDROCHLORIDE, IBUPROFEN, LOPERAMIDE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [WELLY HEALTH PBC]2Legacy NDC, 7 package rows20200424_61a66722-a626-4871-a13c-7c9f3d6d76df.zip
72663-369WELLY TRAVEL MEDICINE KIT (MECLIZINE HYDROCHLORIDE, IBUPROFEN, LOPERAMIDE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [WELLY HEALTH PBC]2Unmatched20200424_61a66722-a626-4871-a13c-7c9f3d6d76df.zip
72663-428WELLY TRAVEL MEDICINE KIT (MECLIZINE HYDROCHLORIDE, IBUPROFEN, LOPERAMIDE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [WELLY HEALTH PBC]2Unmatched20200424_61a66722-a626-4871-a13c-7c9f3d6d76df.zip
72663-567WELLY TRAVEL MEDICINE KIT (MECLIZINE HYDROCHLORIDE, IBUPROFEN, LOPERAMIDE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [WELLY HEALTH PBC]2Unmatched20200424_61a66722-a626-4871-a13c-7c9f3d6d76df.zip
72663-632WELLY TRAVEL MEDICINE KIT (MECLIZINE HYDROCHLORIDE, IBUPROFEN, LOPERAMIDE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [WELLY HEALTH PBC]2Unmatched20200424_61a66722-a626-4871-a13c-7c9f3d6d76df.zip
72663-746WELLY TRAVEL MEDICINE KIT (MECLIZINE HYDROCHLORIDE, IBUPROFEN, LOPERAMIDE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [WELLY HEALTH PBC]2Unmatched20200424_61a66722-a626-4871-a13c-7c9f3d6d76df.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 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-b81b-2440-e053-2a95a90a4b1661a66722-a626-4871-a13c-7c9f3d6d76df2020-04-15WarningsExact identifier
spl id: a359ac07-b81b-2440-e053-2a95a90a4b16
spl set id: 61a66722-a626-4871-a13c-7c9f3d6d76df

Reported adverse events (FAERS/openFDA)#

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