Label: SEVERE DAYTIME NIGHTTIME COLD AND FLU RELIEF MAX STRENGTH- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl, guaifenesin kit
- NDC Code(s): 81179-004-00, 81179-008-00, 81179-804-02
- Packager: YET HEALTH GROUP LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 3, 2024
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- NIGHTTIME SEVERE COLD & FLU Active ingredients (in each softgel)
- DAYTIME SEVERE COLD & FLU Active ingredients (in each softgel)
- NIGHTTIME SEVERE COLD & FLU Purpose
- DAYTIME SEVERE COLD & FLU Purpose
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NIGHTTIME SEVERE COLD & FLU
Uses
Temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion and pressure
- cough due to minor throat and bronchial irritation
- cough to help you sleep
- minor aches and pains
- headache
- fever
- sore throat
- runny nose and sneezing
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
-
DAYTIME SEVERE COLD & FLU
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 (musus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 softgels 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
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.
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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
- NIGHTTIME SEVERE COLD & FLU Ask a doctor before use if you have
- DAYTIME SEVERE COLD & FLU Ask a doctor before use if you have
- NIGHTTIME SEVERE COLD & FLU Ask a doctor or pharmacist before use if you are
- DAYTIME SEVERE COLD & FLU Ask a doctor or pharmacist before use if you are
- NIGHTTIME SEVERE COLD & FLU When using this product
- DAYTIME SEVERE COLD & FLU When using this product
-
NIGHTTIME SEVERE COLD & FLU
Stop use and ask a doctor if
- you gets 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.
-
DAYTIME SEVERE COLD & FLU
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.
- NIGHTTIME SEVERE COLD & FLU Directions
- DAYTIME SEVERE COLD & FLU Directions
- Other information
- NIGHTTIME SEVERE COLD & FLU Inactive ingredients
- DAYTIME SEVERE COLD & FLU Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SEVERE DAYTIME NIGHTTIME COLD AND FLU RELIEF MAX STRENGTH
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl, guaifenesin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81179-804 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81179-804-02 1 in 1 CARTON 09/02/2021 1 1 in 1 BOTTLE; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 40 BOTTLE 40 Part 2 80 BOTTLE 80 Part 1 of 2 SEVERE NIGHTTIME COLD AND FLU RELIEF MAX STRENGTH
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filledProduct Information Item Code (Source) NDC:81179-004 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 SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE (UNII: FZ989GH94E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 1000000 (UNII: HZ58M6D839) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color green Score no score Shape OVAL Size 20mm Flavor Imprint Code IS5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81179-004-00 1 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 Drug M012 09/02/2021 Part 2 of 2 SEVERE DAYTIME COLD AND FLU RELIEF MAX STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filledProduct Information Item Code (Source) NDC:81179-008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape OVAL Size 20mm Flavor Imprint Code IS4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81179-008-00 1 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 Drug M012 09/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/02/2021 Labeler - YET HEALTH GROUP LLC (117763296)