Label: DAYTIME AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hcl / acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
- NDC Code(s): 0363-0775-24
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 19, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DRUG FACTS - Nighttime Cold & Flu
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
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
sneezing
itching of the nose or throatitchy, watery eyes due to hay fever
• controls cough to help you get to sleep
• temporarily reduces fever
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 12 softgels in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily 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
• 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
• diabetes
• high blood pressure
• thyroid disease
• trouble urinating due to enlarged prostate gland
• glaucoma
• 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)
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
When using this product
• 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 vehicle or operating machinery
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 fever, rash, or headache that lasts.
These could be signs of a serious conditionKeep out of reach of children.
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 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.
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- DRUG FACTS - Daytime Cold & Flu
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
• temporarily relieves common cold and flu symptoms:
sinus congestion and pressure
cough
minor aches and pains
headache
nasal congestion
sore throat
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• controls cough to help you get to sleep
• temporarily reduces fever
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 12 softgels in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily 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
• 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
• diabetes
• high blood pressure
• thyroid disease
• trouble urinating due to enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)
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 fever, rash, or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children.
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 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.
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAYTIME AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hcl / acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0775 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0775-24 3 in 1 CARTON 06/01/2022 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BLISTER PACK 16 Part 2 1 BLISTER PACK 8 Part 1 of 2 DAYTIME COLD AND FLU MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hcl capsule, liquid filledProduct Information Item Code (Source) NDC:0363-0750 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape OVAL (OBLONG) Size 21mm Flavor Imprint Code 78 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 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 Drug M012 06/01/2022 Part 2 of 2 NIGHTTIME COLD AND FLU MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filledProduct Information Item Code (Source) NDC:0363-1011 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 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) SODIUM HYDROXIDE (UNII: 55X04QC32I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL (OBLONG) Size 21mm Flavor Imprint Code 72 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 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 Drug M012 06/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/01/2022 Labeler - Walgreens (008965063) Registrant - TIME CAP LABORATORIES INC (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LTD 925822975 manufacture(0363-0775)
