Label: COLD AND FLU SEVERE NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 36800-848-24
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
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 January 18, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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 through the nose
- promotes nasal and/or sinus drainage
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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.
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
- glaucoma
- a sodium-restricted diet
- trouble urinating due to enlarged prostate gland
- 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
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When 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 drowsiness
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.
- Directions
- Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton
NDC: 36800-827-24
*Compare to the active ingredients
in Vicks® Nyquil™ Severe Cold & FluMAXIMUM STRENGTH RELIEF
Night Time
Cold & Flu Relief
SEVEREPAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
ANTIHISTAMINE - DOXYLAMINE SUCCINATE
NASAL DECONGESTANT - PHENYLEPHRINE HCl• Headache, Fever, Sore Throat, Minor Aches & Pains
• Sinus Congestion & Pressure
• Runny Nose & Sneezing • Cough24 SOFTGELS
actual size
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INGREDIENTS AND APPEARANCE
COLD AND FLU SEVERE NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-848 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 6.5 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C Blue NO. 1 (UNII: H3R47K3TBD) Gelatin, Unspecified (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A) Povidone K30 (UNII: U725QWY32X) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sodium Hydroxide (UNII: 55X04QC32I) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape OVAL Size 20mm Flavor Imprint Code 789 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-848-24 2 in 1 CARTON 05/01/2021 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 05/01/2021 Labeler - TOPCO ASSOCIATES LLC (006935977)