Label: CAREONE DAY COLD AND FLU NIGHT COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 41520-820-90 - Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 23, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each liquid gel) DAY Cold & Flu
- Purposes DAY Cold Flu
- Active ingredients (in each liquid gel) NIGHT Cold & Flu
- Purposes NIGHT Cold & Flu
-
Uses
- •
- temporarily relieves these common cold and flu symptoms:
- •
- sinus congestion and pressure
- •
- cough
- •
- minor aches and pains
- •
- headache
- •
- nasal congestion
- •
- sore throat
- •
- runny nose (NIGHT only)
- •
- sneezing (NIGHT only)
- •
- itching of the nose or throat (NIGHT only)
- •
- itchy, watery eyes due to hay fever (NIGHT only)
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
- •
- controls cough to help you get to sleep
- •
- temporarily reduces fever
-
Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- with other drugs containing acetaminophen
- •
- 3 or more alcoholic drinks every day while using these products
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- •
- skin reddening
- •
- blisters
- •
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- •
- 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 these products.
- •
- if you have ever had an allergic reaction to these products or any of their ingredients
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- diabetes
- •
- high blood pressure
- •
- thyroid disease
- •
- trouble urinating due to an enlarged prostate gland
- •
- glaucoma (NIGHT only)
- •
- a breathing problem such as emphysema or chronic bronchitis (NIGHT only)
- •
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- •
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- •
- taking the blood thinning drug warfarin
- •
- taking sedatives or tranquilizers (NIGHT only)
When using these products
- •
- do not use more than directed
- •
- excitability may occur, especially in children (NIGHT only)
- •
- marked drowsiness may occur (NIGHT only)
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
- •
- avoid alcoholic drinks (NIGHT only)
- •
- be careful when driving a motor vehicle or operating machinery (NIGHT only)
Stop use and ask a doctor if
- •
- nervousness, dizziness, or sleeplessness occur
- •
- pain, nasal congestion 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.
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients (DAY only)
- Inactive ingredients (NIGHT only)
- Questions or comments?
-
Package/Label Principal Display Panel
COMBINATION PACK
Compare to the active ingredients in Mucinex® Fast-Max® Day Cold & Flu
DAY COLD & FLU
Pain Reliever/Fever Reducer – Acetaminophen
Cough Suppressant – Dextromethorphan HBr
Expectorant – Guaifenesin
Nasal Decongestant – Phenylephrine HCl
Maximum Strength
Sore Throat, Fever, Chest Congestion, Cough, Nasal Congestion, Sinus Congestion, Sinus Pressure, Headache, Body Pain
Fast Dissolving Liquid Gels
For Ages 12+
Gluten Free
Actual Size
OUR PHARMACISTS RECOMMEND
16 LIQUID GELS (Liquid Filled Capsules)
Compare to the active ingredients in Mucinex® Fast-Max® Night Cold & Flu
NIGHT COLD & FLU
Pain Reliever/Fever Reducer – Acetaminophen
Cough Suppressant – Dextromethorphan HBr
Antihistamine – Doxylamine Succinate
Nasal Decongestant – Phenylephrine HCl
Maximum Strength
Sore Throat, Fever, Itchy Throat, Cough, Nasal Congestion, Sneezing, Runny Nose, Headache, Body Pain
Fast Dissolving Liquid Gels
For Ages 12+
Gluten Free
Actual Size
OUR PHARMACISTS RECOMMEND
8 LIQUID GELS (Liquid Filled Capsules)
-
INGREDIENTS AND APPEARANCE
CAREONE DAY COLD AND FLU NIGHT COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-820 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-820-90 1 in 1 KIT; Type 0: Not a Combination Product 07/23/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 8 BLISTER PACK 16 Part 2 4 BLISTER PACK 8 Part 1 of 2 CAREONE DAY COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filledProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color ORANGE Score no score Shape OVAL Size 25mm Flavor Imprint Code 7G0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 in 1 CARTON 1 2 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 Part 2 of 2 CAREONE NIGHT COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filledProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color GREEN Score no score Shape OVAL Size 20mm Flavor Imprint Code 345 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 in 1 CARTON 1 2 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/23/2019 Labeler - American Sales Company (809183973)