Label: NON DROWSY SEVERE DAYTIME AND NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride, guaifenesin kit
- NDC Code(s): 51316-106-24
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each softgel)
- Purposes
-
Uses
■ temporarily relieves common cold/flu symptoms:
■ nasal congestion ■ sinus congestion & pressure
■ cough due to minor throat & bronchial irritation
■ minor aches & pains ■ headache
■ fever ■ sore throat ■ reduces swelling of nasal passages
■ temporarily restores freer breathing through the nose
■ promotes nasal and/or sinus drainage
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. -
Warnings
Liver warning 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 productAllergy 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 ■ high blood pressure
■ thyroid disease ■ diabetes
■ 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, chronic bronchitis, or emphysemaStop use and ask a doctor if
■ you get nervous, dizzy or sleepless
■ 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. -
Directions
■ take only as directed - see Overdose warning
■ do not exceed 4 doses per 24 hoursadults & children 12 years & over 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use ■ when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing
- Other information
- Inactive ingredients
- Drug Facts
- Active ingredients (in each softgel)
- Purposes
-
Uses
■ temporarily relieves common cold/flu symptoms:
■ nasal congestion ■ sinus congestion & pressure
■ cough due to minor throat & bronchial irritation
■ cough to help you sleep ■ minor aches & pains ■ headache
■ fever ■ sore throat ■ runny nose & sneezing
■ reduces swelling of nasal passages
■ temporarily restores freer breathing thr -
Warnings
Liver warning This product contains acetaminophen. Severe liverdamage may occur if you take
■ more than 4 doses in 24 hours, which is the maximum dailyamount for this product
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this productAllergy 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.
■ to make a child sleepAsk a doctor before use if you have
■ liver disease ■ heart disease ■ high blood pressure
■ thyroid disease ■ diabetes ■ 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 glandAsk a doctor or pharmacist before use if you are
■ taking sedatives or tranquilizers
■ taking the blood thinning drug warfarinWhen using this product
■ do not use more than directed
■ 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, and tranquilizers may increase drowsinessStop use and ask a doctor if
■ you get nervous, dizzy or sleepless
■ 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. - Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
NON DROWSY SEVERE DAYTIME AND NIGHTTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride, guaifenesin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-106 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-106-24 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 11/10/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 0 BLISTER PACK 1 Part 2 0 BLISTER PACK 1 Part 1 of 2 NON DROWSY SEVERE DAYTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filledProduct Information Item Code (Source) NDC:51316-104 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 5 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 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 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 Size 20mm Flavor Imprint Code 341;A13 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 12 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 11/10/2022 Part 2 of 2 SEVERE NIGHTTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filledProduct Information Item Code (Source) NDC:51316-105 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 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) SHELLAC (UNII: 46N107B71O) SODIUM HYDROXIDE (UNII: 55X04QC32I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL Size 20mm Flavor Imprint Code 116;A07 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 12 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 11/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 11/10/2022 Labeler - CVS Pharmacy (062312574)
