FDA Label for Welly Travel Medicine Kit
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USE
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- WHEN USING THIS PRODUCT
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PAIN RELIEF AND FEVER REDUCER, 16 TABLETS
- ACTIVE INGREDIENT (IN EACH BROWN TABLET)
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREASTFEEDING,
- ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)
- ACTIVE INGREDIENT (IN EACH CAPLET)
- WHEN USING THIS PRODUCT,
- ACTIVE INGREDIENT (IN EACH TABLET)
- ASK A DOCTOR OR PHARMACIST BEFORE
- STOP USE AND ASK A DOCTOR
- PACKAGE LABELING:(72663-205-48)
- OTHER
- PACKAGE LABELING:(72663-428-48)
- PACKAGE LABELING:(72663-746-48)
- PACKAGE LABELING:(72663-567-48)
- PACKAGE LABELING:(72663-369-48)
Welly Travel Medicine Kit Product Label
The following document was submitted to the FDA by the labeler of this product Welly Health Pbc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Meclizine HCI 25 mg
Purpose
Antiemetic
Pain reliever/fever reducer
Antigas
Anti-diarrheal
Nighttime sleep-aid
Use
for the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness
relieves bloating, pressure, and fullness commonly referred to as gas.
controls symptoms of diarrhea, including Travelers’ Diarrhea
helps to reduce difficulty in falling asleep
Do Not Use
for children under 12 years of age unless directed by a doctor
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
you have bloody or black stool.
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.
- A fever
- Mucus in the stool
- A history of liver disease
- A history of abnormal heart rhythm
- 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 sedatives or tranquilizers.
if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.
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
- take with food or milk if stomach upset occurs
- avoid alcoholic beverages
- take only at bedtime
If Pregnant Or Breast-Feeding,
ask a health professional before use.
ask a health professional before use.
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
In case of overdose, get Medical help or contact a Poison Control Center (1-800-222-1222) 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
- 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
- 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
- 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: 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
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 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
- 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
- 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
- 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
- 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
corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxide
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
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
corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide
dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
1-833-BE-WELLY (1-833-239-3559)
1-833-BE-WELLY
1-833-BE-WELLY (1-833-239-3559)
1-833-BE-WELLY
1-833-BE-WELLY
Pain Relief And Fever Reducer, 16 Tablets
Active Ingredient (In Each Brown Tablet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
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
- 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.
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
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.
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
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
- 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 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.
Active Ingredient (In Each Chewable Tablet)
Simethicone 125 mg
Active Ingredient (In Each Caplet)
Loperamide HCI 2 mg
When Using This Product,
tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.
Active Ingredient (In Each Tablet)
Doxylamine succinate 25 mg
Ask A Doctor Or Pharmacist Before
use if you are taking any other drugs.
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.
Package Labeling:(72663-205-48)
Other
Package Labeling:(72663-428-48)
Package Labeling:(72663-746-48)
Package Labeling:(72663-567-48)
Package Labeling:(72663-369-48)
* Please review the disclaimer below.