![GOOD SENSE SEVERE NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [L. PERRIGO COMPANY]](https://medic.hrt.org//dailymed/images/f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2/image-01.jpg)
| NDC | 0113-0763-34, 0113-0763-40 |
| Set ID | f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | L. Perrigo Company |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 30 mL)
- Purpose
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Uses
temporarily relieves common cold/flu symptoms:
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- nasal congestion
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- sinus congestion and pressure
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- minor aches and pains
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- headache
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- fever
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- sore throat
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- runny nose and sneezing
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- cough due to minor throat and bronchial irritation
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- cough to help you sleep
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- reduces swelling of nasal passages
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- promotes nasal and/or sinus drainage
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- temporarily restores freer breathing through the nose
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
When using this product
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- do not use more than directed
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- excitability may occur, especially in children
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- marked drowsiness may occur
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- avoid alcoholic drinks
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- be careful when driving a motor vehicle or operating machinery
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- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
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- you get nervous, dizzy or sleepless
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- pain, nasal congestion, or cough gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- 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?
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Package/Label Principal Display Panel
Maximum Strength Relief
Pain Reliever, Fever Reducer
Nasal Decongestant
Cough Suppressant, Antihistamine
Severe NightTime Cold & Flu
Acetaminophen
Dextromethorphan HBr
Doxylamine Succinate
Phenylephrine HC1
● Headache, Fever, Sore Throat, Minor Aches & Pains ● Cough
● Sneezing, Runny Nose
● Nasal/Sinus Congestion & Sinus Pressure
Berry Flavor
Compare to active ingredients of Vicks® NyQuil® Severe
8 FL OZ (237 mL)
Alcohol Free
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INGREDIENTS AND APPEARANCE
GOOD SENSE SEVERE NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0763 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, UNSPECIFIED FORM (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:0113-0763-34 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2013 2 NDC:0113-0763-40 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/19/2013 Labeler - L. Perrigo Company (006013346)
