Label: SEVERE COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquid
- NDC Code(s): 49580-0416-8
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 25, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 30 mL)
- Purposes
-
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
- runny nose and sneezing
- cough to help you sleep
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarges prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are taking
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not use more than directed (see overdose warning)
- 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
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or last more than 3 days
- redness or swelling is present
- cough comes back, or occurs with rash or headache that lasts.
These could be a signs of a serious conditions.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.
-
Directions
- take only as directed - see Overdose warning
- mL = milliliter
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- do not exceed 4 doses per 24 hours
- adults and children 12 years and over: 30 mL every 4 hours
- children under 12 years of age: do not use
- When using Day Time or Night Time products, carefully read each label to ensure correct dosing.
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Compare to active ingredients in Vicks® NyQuil® Severe Cold & Flu*
maximum strength
severe night time cold & flu
cold & flu
Acetaminophen
dextromethorphan HBr
doxylamine succinate
phenylephrine HCI
relieves:
- aches, fever & sore throat
- cough
- runny nose & sneezing
- nasal & sinus Congestion
alcohol free
berry flavor
FL OZ (mL)
*This product is not manufactured or distributed by Procter & Gamble, distributor or Vicks® NyQuil® Severe Cold & Flu.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
- Product Label
-
INGREDIENTS AND APPEARANCE
SEVERE COLD AND FLU NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0416 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0416-8 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/31/2015 Labeler - P & L Development, LLC (101896231)
