| NDC | 36800-562-08 |
| Set ID | 90358b3c-63c9-4aef-a241-9a6e588535d5 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | TopCare Health |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
| Product Number | |
| Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
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
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Uses
Daytime
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- cough due to minor throat & bronchial irritation
- •
- sore throat
- •
- headache
- •
- minor aches & pains
- •
- fever
- Nighttime
temporarily relieves common cold/flu symptoms:
- •
- cough due to minor throat & bronchial irritation
- •
- sore throat
- •
- headache
- •
- minor aches & pains
- •
- fever
- •
- runny nose & sneezing
-
Warnings
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
Allergy Alert: Acetaminophen may cause severe skin reaction. Symptom may include:
- •
- Skin reddening
- •
- Blisters
- •
- Rash
If a skin reaction occurs, stop use and seek medical help right away.
- Nighttime
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 every day while using this product
Allergy Alert: Acetaminophen may cause severe skin reaction. Symptom may include:
- •
- Skin reddening
- •
- Blisters
- •
- Rash
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.
- Nighttime
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
- Daytime
- Nighttime
- •
- 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.
- Nighttime
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- 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
- Daytime
- •
- 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
- Nighttime
- •
- 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.
- Nighttime
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
Daytime: When using this product, do not use more than directed.
- Nighttime
- •
- 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
- Daytime
- •
- 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.
These could be signs of a serious condition.
Nighttime
- •
- 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.
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.
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Directions
Daytime
- •
- take only as directed - see Overdose warning
- •
- do not exceed 4 doses per 24 hours
adults & children 12yrs & over
one cup every 4 hrs
children under 12yrs
do not use
- •
- 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
- Nighttime
- •
- take only as directed - see Overdose warning
- •
- do not exceed 4 doses per 24 hours
adults & children 12yrs & over
one cup every 6 hrs
children under 12yrs
do not use
- •
- 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.
- 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
- Other information
- Inactive ingredients
- Questions or comments?
-
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
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 CupsK-CUP®/REAL CUP® POD COMPATIBLE
ACETAMINOPHEN
Pain reliever/Fever reducer
DEXTROMETHORPHAN HBr
Cough suppressant
DOXYLAMINE SUCCINATEAntihistamine
Relieves:
- •
- Headache, fever, sore throat
- •
- Minor aches and pains
- •
- Sneezing, runny Nose
- •
- Cough
- Honey Lemon Flavor Infused Chamomile & White Tea Flavors
- Naturally and Artificially Flavored
- Alcohol free
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.
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INGREDIENTS AND APPEARANCE
TOPCARE HEALTH NON DROWSY DAYTIME COLD AND FLU RELIEF AND NIGHTTIME COLD AND FLU RELIEF DAY AND NIGHT COMBO PACK
acetaminophen ,dextromethorphan hydrobromide and phenylephrine hcl ,acetaminophen,dextromethorphan hbr,doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-562 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-562-08 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 03/06/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 4 CUP 4 Part 2 4 CUP 4 Part 1 of 2 TOPCARE HEALTH DAYTIME COLD AND FLU RELIEF DAYTIME
acetaminophen ,dextromethorphan hydrobromide and phenylephrine hcl powder, for solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) ISOMALT (UNII: S870P55O2W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PINK Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 in 1 KIT 1 1 in 1 CUP; 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 03/06/2019 Part 2 of 2 TOPCARE HEALTH NIGHTTIME COLD AND FLU RELIEF NIGHTTIME
acetaminophen,dextromethorphan hbr,doxylamine succinate powder, for solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ISOMALT (UNII: S870P55O2W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color ORANGE Score Shape Size Flavor HONEY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 in 1 KIT 1 1 in 1 CUP; 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 03/06/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/06/2019 Labeler - TopCare Health (006935977)
