Label: MAXIMUM STRENGTH DAYTIME SEVERE AND NIGHTTIME COLD AND FLU- daytime- acetaminophen, dextromethorphan hbr, guaifenesin, nighttime - acetaminophen, diphenhydramine hci kit
- NDC Code(s): 11673-794-01
- Packager: TARGET Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 8, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients for Nighttime (in each 20 mL)
- Active ingredients for Daytime (in each 20 mL)
- Purpose for Nighttime
- Purpose for Daytime
-
Uses
Nighttime
- temporarily relieves these common cold and flu symptoms
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- runny nose
- sneezing
- temporarily reduces fever
- controls cough to help you get to sleep
Daytime
- temporarily relieves these common cold and flu symptoms
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
-
Warnings
NIGHTTIME and DAYTIME
Liver warning: This product 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 this product.
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
Nighttime
- with any 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 diphenhydramine, even one used on the skin
- 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
- for children under 12 years of age
Daytime
- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- for children under 12 years of age
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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
Nighttime
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Daytime
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
Nighttime
- you are taking the blood thinning drug warfarin
- you are taking sedative or tranquilizers
Daytime
- taking the blood thinning drug warfarin
When using these products
Nighttime
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicile or operating machinery
Daytime
- do not use more than directed
Stop use and ask a doctor if
Nighttime
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 7 days
- fever gets worse, or last 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 a signs of a serious condition
Daytime
- 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.
Nighttime and DayTime
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
-
Directions
Nighttime
- do not take more than directed (see overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL = mililiter
- dose as follows or as directed by a doctor
- adults and children 12 years and older: 20 mL every 4 hours while symptoms last
- children under 12 years of age: do not use
Daytime
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24-hours period
- measure only with dosing cup provided. Do not use any other dosing device.
- dose as follows or as directed by a doctor
- keep dosing cup with product
- mL = milliliter
- adults and children 12 years of age and older: 20 mL every 4 hours
- children under 12 years of age: do not use
- Other information
-
Inactive ingredients
Nighttime
citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Daytime
citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
-
Principal Display Panel
NIGHTTIME
Compare to active ingredients in Maximum Strength Mucinex®Fast-Max® Night Time Cold & Flu**
maximum strength
nighttime
Cold & Flu
acetaminophen (pain reliever / fever reducer)
diphenhydramine HCI (antihistamine / cough suppressant)
phenylephrine HCI (nasal decongestant)
Relieves aches, fever, sore throat
controls cough
relieves nasal congestion
relieves runny nose and sneezing
AGES 12 + YEARS
DAYTIME
Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® Day Time Severe Cold*
maximum strength
daytime
Severe Cold
acetaminophen (pain reliever / fever reducer)
dextromethorphan HBr (cough suppressant)
guaifenesin (expectorant)
phenylephrine HCI (nasal decongestant)
Relieves aches, fever & sore throat
Controls Cough
relieves nasal and chest congestion
thins and loosens mucus
AGES 12 + YEARS
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This prodect is not manufactured or distributed by Recitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Day Time Severe Cold.
**This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Night Time Cold & Flu.
Dist. by Target Corp.
Minneapolis, MN 55403
Product of U.S.A.
©2016 Target Brands, Inc.
Questions? Call 1-800-910-6874
- Product Label
-
INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH DAYTIME SEVERE AND NIGHTTIME COLD AND FLU
daytime- acetaminophen, dextromethorphan hbr, guaifenesin, nighttime - acetaminophen, diphenhydramine hci kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-794 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-794-01 1 in 1 KIT; Type 0: Not a Combination Product 05/01/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 177 mL Part 2 1 BOTTLE, PLASTIC 177 mL Part 1 of 2 MAXIMUM STRENGTH DAYTIME SEVERE COLD
acetaminophen, dextromethorphan hbr, guaifenesin liquidProduct Information Item Code (Source) NDC:11673-709 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) GLYCERIN (UNII: PDC6A3C0OX) PROPYL GALLATE (UNII: 8D4SNN7V92) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 05/01/2024 Part 2 of 2 MAXIMUM STRENGTH NIGHTTIME COLD AND FLU
acetaminophen, diphenhydramine hci liquidProduct Information Item Code (Source) NDC:11673-711 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg in 20 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) PROPYL GALLATE (UNII: 8D4SNN7V92) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 05/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 05/01/2024 Labeler - TARGET Corporation (006961700) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 677604129 manufacture(11673-794)
