FDA Label for Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING:
- SORE THROAT WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- DAYTIME: WHEN USING THIS PRODUCT, DO NOT USE MORE THAN DIRECTED.
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack Product Label
The following document was submitted to the FDA by the labeler of this product Topcare Health. 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.
Other
Drug Facts Daytime Cold & Flu Relief
Daytime
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Nighttime
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Otc - Purpose
Active ingredients (in each single serve cup) | Purposes |
---|---|
Acetaminophen 650 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 20 mg | Cough suppressant |
Phenylephrine HCl 10 mg | Nasal decongestant |
Drug Facts Nighttime Cold & Flu Relief
Active ingredients (in each single serve cup) | Purposes | ||
---|---|---|---|
Acetaminophen 650 mg | Pain reliever/Fever reducer | ||
Dextromethorphan HBr 30 mg | Cough suppressant | ||
Doxylamine succinate 12.5 mg | Antihistamine |
Uses
Daytime
temporarily relieves common cold/flu symptoms:
• nasal congestion• cough due to minor throat & bronchial irritation• sore throat• headache• minor aches & pains• fever• cough due to minor throat & bronchial irritation• sore throat• headache• minor aches & pains• fever• runny nose & sneezing
temporarily relieves common cold/flu symptoms:
Liver Warning:
Daytime
This product contains acetaminophen.
Severe liver damage may occur if you take
• more than 4 doses in 24 hours, which is the maximum daily amount for this product• with other drugs containing acetaminophen• 3 or more alcoholic drinks daily while using this product• Skin reddening• Blisters• Rash• more than 4 doses in 24 hours, which is the maximum daily amount for this product• with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this product• Skin reddening• Blisters• Rash
Allergy Alert: Acetaminophen may cause severe skin reaction. Symptom may include:
If a skin reaction occurs, stop use and seek medical help right away.
This product contains acetaminophen.
Severe liver damage may occur if you take
Allergy Alert: Acetaminophen may cause severe skin reaction. Symptom may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore Throat Warning:
Daytime
If sore throat is severe, lasts for more than 2 days, is accompanied with or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
If sore throat is severe, lasts for more than 2 days, is accompanied with or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do Not Use
• with any other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
• liver disease• heart disease• thyroid disease• diabetes• high blood pressure• trouble urinating due to enlarged prostate gland• cough that occurs with too much phlegm (mucus)• persistent or chronic cough such as occurs with smoking, asthma, or emphysema• liver disease• glaucoma• cough that occurs with too much phlegm (mucus)• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema• trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
Daytime
taking the blood thinning drug warfarin.
Daytime: When Using This Product, Do Not Use More Than Directed.
• excitability may occur, especially in children• marked drowsiness may occur• avoid alcoholic drinks• be careful when driving a motor vehicle or operating machinery• alcohol, sedatives, & tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
• you get nervous, dizzy or sleepless• pain, nasal congestion or cough gets worse or lasts more than 5 days(children) or 7 days(adults)• fever gets worse or lasts more than 3 days• redness or swelling is present• new symptoms occur• cough comes back, or occurs with rash or headache that lasts.• pain or cough gets worse or lasts more than 7 days• fever gets worse or lasts more than 3 days• redness or swelling is present• new symptoms occur• cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Nighttime
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Daytime
• take only as directed - see Overdose warning• do not exceed 4 doses per 24 hours• place single–serve cup in compatible brewer• use a minimum of 8 oz of water• when finished, the single serve cups are hot and may drip. Tilt the cup during removal to avoid dripping.• DO NOT REMOVE THE FOIL SEAL as the cup will not work properly in any single serve compatible brewer and could result in hot water burns.• Flush brewer after use• take only as directed - see Overdose warning• do not exceed 4 doses per 24 hours• place single-serve cup in any compatible brewer†• use a minimum of 8 oz of water• when finished, the single serve cups are hot and may drip.• DO NOT REMOVE THE FOIL SEAL as the cup will not work properly in any single serve compatible brewer and could result in hot water burns.• Flush brewer after use
adults & children 12yrs & over | one cup every 4 hrs |
children under 12yrs | do not use |
adults & children 12yrs & over | one cup every 6 hrs |
children under 12yrs | do not use |
Other Information
Daytime
• store at room temperature
Inactive Ingredients
Daytime
citric acid, FD&C Red No. 40, flavors, isomalt, silica, sucralose
Nighttime
citric acid, FD&C Yellow No.6, flavors, isomalt, silica, sucralose
Questions Or Comments?
Daytime
1-866-467-2748
Nighttime
1-866-467-2748
Principal Display Panel
DAY & NIGHT COMBINATION PACK
TopCare Health™
NDC 36800-562-08
COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL® COLD & FLU*
Non-Drowsy
Daytime
Cold & Flu Relief
Single serve
Cups
COMPATIBLE WITH KEURIG® K- CUP Brewers & Keurig 2.0 Brewing System, Realcup® Brewers, Remington Icoffe® Express™ Brewers and other single-serve pod machine and personal cup brewers,
Day Time Cold & Flu
Pain reliever/Fever reducer, ACETAMINOPHEN
Cough suppressant
DEXTROMETHORPHAN Habra
Nasal decongestant
PHENYLEPHRINE HCl
Relieves:
• Headache, fever, sore throat• Minor aches & pains• Nasal congestion• Cough• Headache, fever, sore throat• Minor aches and pains• Sneezing, runny Nose• Cough
Berry Flavor infused with Menthol & Green Tea Flavors
Naturally and Artificially Flavored
Alcohol free
4 DAYTIME CUPS
Compare to the active ingredients in Vicks® NyQuil®Cold & Flu*
Nighttime
Cold & Flu Relief
Single Serve Cups
K-CUP®/REAL CUP® POD COMPATIBLE
ACETAMINOPHEN
Pain reliever/Fever reducer
DEXTROMETHORPHAN HBr
Cough suppressant
DOXYLAMINE SUCCINATE
Antihistamine
Relieves:
4 NIGHTTIME CUPS
8 TOTAL SINGLE SERVE CUPS
Our single serve cold and flu relief cups are a warm and easy way to feel better fast. Just use our cups as you would any other single serve cup in your single serve machine for a great- tasting, flu-relieving drink anytime .Whether you need a non- drowsy way to get through a long day ahead ,or you are finally tucking yourself into bed at night, take a moment and toast to relief.
*This product is not manufactured or distributed by Procter and Gamble Company, owner of the registered trademark Vicks® DayQuil ®Cold & Flu and Vicks® NyQuil® Cold &Flu.
†COMPATIBLE WITH KEURIG® K- CUP® BREWERS & Keurig 2.0 BREWING SYSTEMS.
THIS PRODUCT IS NOT AFFILIATED WITH KEURIG, INC.
Distributed by: TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO RARA0219
QUESTIONS? 1-888-423-0139
www.topcarebrand.com
QualityGuarantee
This TopCare product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.
PATENT PENDING
TAMPER EVIDENT POUCH: THIS PACKAGE IS SAFETY SEALED & CHILD RESISTANT. PRODUCT IS PACKEGED IN INDIVIDUAL SEALED POUCHES. DO NOT USE IF SEALED CUP IS TORN AND BROKEN. |
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD. |
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 4 DOSES IN ANY 24 –HOUR PERIOD. |
DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR. |
* Please review the disclaimer below.