Label: NON DROWSY DAYTIME AND NIGHTTIME SINUS CONGESTION AND COUGH RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-629-20 - Packager: CVS PHARMACY, INC.
- 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 February 11, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Non Drowsy DAYTIME Sinus Congestion and Cough Relief Active ingredients (in each softgel)
- NIGHTTIME Sinus Congestion and Cough Relief Active ingredients (in each softgel)
- Purposes
- Purposes
- Uses
- Uses
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Non Drowsy DAYTIME Sinus Congestion and Cough Relief
Warnings
Liver warning
These products contain acetaminophen. Severe liver damage may occur if you take
- more than 4000 mg of Acetaminophen 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 product
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.
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.
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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough with excessive phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- pain, cough, or nasal congestion 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.
- nervousness, dizziness, or sleeplessness occurs
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Nighttime Sinus Congestion and Cough Relief
Warnings
Liver warning
These products contain acetaminophen. Severe liver damage may occur if you take
- more than 4000 mg of Acetaminophen 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 product
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.
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.
Do not use to sedate children.
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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough with excessive phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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 exceed recommended dosage
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- pain, cough, or nasal congestion 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.
- nervousness, dizziness, or sleeplessness occurs
- Non Drowsy DAYTIME Sinus Congestion and Cough Relief Directions
- Nighttime Sinus Congestion and Cough Relief Directions
- Non Drowsy DAYTIME Sinus Congestion and Cough Relief Other information
- Nighttime Sinus Congestion and Cough Relief Other information
- Non Drowsy DAYTIME Sinus Congestion and Cough Relief Inactive ingredients
- Nighttime Sinus Congestion and Cough Relief Inactive ingredients
- Non Drowsy DAYTIME Sinus Congestion and Cough Relief
- Nighttime Sinus Congestion and Cough Relief
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PRINCIPAL DISPLAY PANEL
CVS NON-DROWSY DAYTIME and NIGHTTIME Sinus Congestion and Cough Relief 20ct
Compare to the active ingredients in
Alka-Seltzer PLUS® Maximum Strength Severe Congestion & Cough Day & Night Liquid Gels*
Daytime NON-DROWSY
Sinus Congestion & Cough Releif
ACETAMINOPHEN- Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Nasal & Sinus congestion; Sinus Pressure; Headache & body ache; Cough
12 SOFTGELS
NIGHTTIME
Sinus Congestion & Cough Relief
ACETAMINOPHEN- Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
DOXYLAMINE SUCCINATE - Antihistamine
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Sinus Congestion & Pressure; Headache & pain; Runny nose & sneezing; Cough
8 SOFTGELS
20 TOTAL
THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND
TAMPER-EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT
*This product is not manufactured or distributed by Bayer
Healthcare LLC, owner of the registered trademark
Alka-Seltzer PLUS® Maximum Strength Severe Sinus Contestion & Cough Day & Night Liquid Gels.
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INGREDIENTS AND APPEARANCE
NON DROWSY DAYTIME AND NIGHTTIME SINUS CONGESTION AND COUGH RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-629 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-629-20 1 in 1 CARTON; Type 0: Not a Combination Product 02/11/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 12 Part 2 1 BLISTER PACK 8 Part 1 of 2 NON DROWSY DAYTIME SINUS CONGESTION AND COUGH RELIEF
acetaminophen, dextromethorphan hydrobromide, 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 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 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange (transparent) Score no score Shape CAPSULE (oblong) Size 21mm Flavor Imprint Code 512 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 final part341 02/11/2020 Part 2 of 2 NIGHTTIME SINUS CONGESTION AND COUGH RELIEF
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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 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 (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SHELLAC (UNII: 46N107B71O) SODIUM HYDROXIDE (UNII: 55X04QC32I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green (transparent) Score no score Shape CAPSULE (oblong) Size 21mm Flavor Imprint Code 116 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 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 final part341 02/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/11/2020 Labeler - CVS PHARMACY, INC. (062312574) Registrant - Spirit Pharmaceuticals LLC (179621011) Establishment Name Address ID/FEI Business Operations MEDGEL PRIVATE LIMITED 677385498 manufacture(69842-629)