WELLY TRAVEL MEDICINE KIT- meclizine hydrochloride, ibuprofen, loperamide hydrochloride, doxylamine succinate kit

Welly Travel Medicine Kit by

Drug Labeling and Warnings

Welly Travel Medicine Kit by is a Otc medication manufactured, distributed, or labeled by Welly Health PBC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Motion Sickness Relief, 8 tablets

Drug Facts

Active ingredient (in each tablet)

Meclizine HCI 25 mg

Purpose

Antiemetic

Use

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

Warnings

Do not use

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

Ask a doctor before use if you have

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 taking sedatives or tranquilizers.

When using this product

• 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,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• 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

• 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

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

Questions or comments?

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

Pain Relief and Fever Reducer, 16 tablets

Drug Facts

Active ingredient (in each brown tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

Warnings

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

• 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

• 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

• 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

• take with food or milk if stomach upset occurs

Stop use and ask a doctor if

• 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,

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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• 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

• 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

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?

1-833-BE-WELLY

Gas Relief, 12 chewable tablets

Drug Facts

Active ingredient (in each chewable tablet)

Simethicone 125 mg

Purpose

Antigas

Use

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

Warning

Keep out of reach of children.

Directions

• 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

• 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

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?

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

Anti-Diarrheal, 12 tablets

Drug Facts

Active ingredient (in each caplet)

Loperamide HCI 2 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

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

you have bloody or black stool.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use

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

When using this product,

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

Stop use and ask a doctor if

• 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,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• 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

• 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

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?

1-833-BE-WELLY

Sleep Aid, 8 tablets

Drug Facts

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty in falling asleep

Warnings

Ask a doctor before use if you have

• 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

use if you are taking any other drugs.

When using this product

• avoid alcoholic beverages
• take only at bedtime

Stop use and ask a doctor

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,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get Medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• 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

• 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

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

Questions or comments?

1-833-BE-WELLY

Package Labeling:(

72663-205-48)

undefined

Package Labeling:(

72663-428-48)

Package Labeling:(

72663-746-48)

Package Labeling:(

72663-567-48)

Package Labeling:(

72663-369-48)

INGREDIENTS AND APPEARANCE

WELLY TRAVEL MEDICINE KIT 
meclizine hydrochloride, ibuprofen, loperamide hydrochloride, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72663-205

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-205-48	1 in 1 KIT	04/06/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	8
Part 2	1 BOTTLE	16
Part 3	2 BLISTER PACK	12
Part 4	1 BLISTER PACK	12
Part 5	1 BLISTER PACK	8

Part 1 of 5

MOTION SICKNESS RELIEF 
meclizine hydrochloride tablet

Product Information
Item Code (Source)	NDC: 72663-632
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	44403
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-632-48	8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	04/06/2020

Part 2 of 5

PAIN RELIEF AND FEVER REDUCER 
ibuprofen tablet

Product Information
Item Code (Source)	NDC: 72663-428
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44291
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-428-48	16 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/06/2020

Part 3 of 5

GAS RELIEF 
dimethicone tablet, chewable

Product Information
Item Code (Source)	NDC: 72663-746
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	14mm
Flavor		Imprint Code	44608
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-746-48	2 in 1 KIT
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	04/06/2020

Part 4 of 5

ANTI DIARRHEAL 
loperamide hydrochloride tablet

Product Information
Item Code (Source)	NDC: 72663-567
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	green (Light)	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	44375
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-567-48	12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076497	04/06/2020

Part 5 of 5

SLEEP AID 
doxylamine succinate tablet

Product Information
Item Code (Source)	NDC: 72663-369
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	25 mg

Inactive Ingredients
Ingredient Name	Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	blue	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	44386
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-369-48	8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part336	04/06/2020

Labeler - Welly Health PBC (116766884)