Label: NIGHT TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
- NDC Code(s): 49580-0342-1, 49580-0342-2
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 May 22, 2023
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 15 mL)
- Purposes
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
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
- to make a child sleepy
- 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
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
- liver disease
- glaucoma
- breathing problems
- chronic bronchitis
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus)
Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers
- 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
- redness or swelling is present
- new symptoms occur
- fever gets worse or last more than 3 days
- pain or cough gets worse or last more than 7 days
- 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 (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- take only as recommended (see overdose warning)
- do not exceed 4 doses per 24 hours
- use dosing cup provided
- mL= milliliter
age dose adults & children 12 yrs and over 30 mL every 6 hours children 4 to 11 yrs do not use unless directed by a doctor children under 4 yrs 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?
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Principal Display Panel
Compare to active ingredients in Vicks® NyQuil®*
night time
cold & flu
Acetaminophen
dextromethorphan HBr
doxylamine succinate
relieves:
- aches, fever & sore throat
- cough
- runny nose & sneezing
for ages 12 & over
alcohol 10%
Cherry flavor
FL OZ (mL)
*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
- Product Label
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INGREDIENTS AND APPEARANCE
NIGHT TIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0342 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 15 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg in 15 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0342-2 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2015 12/31/2025 2 NDC:49580-0342-1 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2015 12/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/28/2015 12/31/2025 Labeler - P & L Development, LLC (101896231)
