CAREONE DAY COLD AND FLU NIGHT COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate 
American Sales Company

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American Sales Company Day Cold & Flu Night Cold & Flu Drug Facts

Active ingredients (in each liquid gel) DAY Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes DAY Cold Flu

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Active ingredients (in each liquid gel) NIGHT Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purposes NIGHT Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see Overdose warning)
do not take more than 10 liquid gels in any 24-hour period
adults and children 12 years of age and older: take 2 liquid gels every 4 hours
children under 12 years of age: do not use

Other information

store at 20-25°C (68-77°F)

Inactive ingredients (DAY only)

edible ink*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

*may contain this ingredient

Inactive ingredients (NIGHT only)

D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

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)

day cold and flu night cold and flu image 1
day cold and flu night cold and flu image 2
CAREONE DAY COLD AND FLU NIGHT COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-820
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-820-901 in 1 KIT; Type 0: Not a Combination Product07/23/201901/31/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 18 BLISTER PACK 16 
Part 24 BLISTER PACK
Part 1 of 2
CAREONE DAY COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize25mm
FlavorImprint Code 7G0
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 CARTON
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM012
Part 2 of 2
CAREONE NIGHT COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize20mm
FlavorImprint Code 345
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 CARTON
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/23/201901/31/2021
Labeler - American Sales Company (809183973)

Revised: 10/2023
 
American Sales Company