NDC | 21130-091-40, 21130-129-40, 21130-164-02 |
Set ID | fc3ce8eb-fd3e-4f56-aa8e-70e86c9f099c |
Category | HUMAN OTC DRUG LABEL |
Packager | Safeway |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- Nighttime Severe Cold & FluActive ingredients (in each 30 mL)
- Purpose
-
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- minor aches and pains
- •
- headache
- •
- fever
- •
- sore throat
- •
- runny nose and sneezing
- •
- cough due to minor throat and bronchial irritation
- •
- cough to help you sleep
- •
- reduces swelling of nasal passages
- •
- promotes nasal and/or sinus drainage
- •
- temporarily restores freer breathing through the nose
-
Warnings
Liver warning: This product contains 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
- •
- 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
-
Ask 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 such as emphysema or chronic bronchitis
- •
- trouble urinating due to an enlarged prostate gland
- •
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- •
- a sodium-restricted diet
- Ask a doctor or pharmacist before use if you are
- When using this product
-
Stop 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.
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Daytime Severe Cold & FluActive ingredients (in each 15 mL)
- Purpose
-
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- cough due to minor throat and bronchial irritation
- •
- minor aches and 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
- •
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- •
- child takes more than 5 doses in 24 hours
- •
- taken with other drugs containing acetaminophen
- •
- adult has 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
- •
- 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
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
-
Stop use and ask a doctor if
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- •
- 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,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
VALUE PACK
Compare to Vicks® DayQuil® Severe active ingredients
Quality Guaranteed
SEVERE
Maximum Strength
Non-Drowsy
Daytime Severe Cold & Flu Relief
ACETAMINOPHEN 325 mg
Pain Reliever, Fever Reducer
DEXTROMETHORPHAN HBr 10 mg
Cough Suppressant
GUAIFENESIN 200 mg
Expectorant
PHENYLEPHRINE HCl 5 mg
Nasal Decongestant
ORIGINAL FLAVOR
12 FL OZ (355 mL)
Alcohol Free
Compare to Vicks® NyQuil® Severe active ingredients
Quality Guaranteed
SEVERE
Maximum Strength
Nighttime Severe Cold & Flu Relief
ACETAMINOPHEN 650 mg
Pain Reliever, Fever Reducer
DEXTROMETHORPHAN HBr 20 mg
Cough Suppressant
DOXYLAMINE SUCCINATE 12.5 mg
Antihistamine
PHENYLEPHRINE HCl 10 mg
Nasal Decongestant
BERRY FLAVOR
12 FL OZ (355 mL)
Alcohol Free
-
INGREDIENTS AND APPEARANCE
SIGNATURE CARE DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-164 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-164-02 1 in 1 CARTON; Type 0: Not a Combination Product 06/01/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 355 mL Part 2 1 BOTTLE 355 mL Part 1 of 2 SIGNATURE CARE NIGHTTIME SEVERE COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solutionProduct Information Item Code (Source) NDC:21130-129 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED (clear, dark) Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-129-40 355 mL in 1 BOTTLE; 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 01/24/2016 Part 2 of 2 SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionProduct Information Item Code (Source) NDC:21130-091 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color ORANGE (clear) Score Shape Size Flavor FRUIT, MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-091-40 355 mL in 1 BOTTLE; 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 01/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2017 Labeler - Safeway (009137209)