Label: DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF- acetaminophen dextromethorphan hbr guaifenesin phenylephrine hci doxylaminesucinate kit
- NDC Code(s): 49580-0813-6
- 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 17, 2023
If you are a consumer or patient please visit this version.
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- Active ingredients (in each 15 mL) DAYTIME
- Active ingredients for (in each 30 mL) NIGHTTIME
- Purposes for Day Time
- Purpose for Night Time
-
Uses
DAYTIME
- temporarily relieves common cold and flu symptoms
- nasal congestion
- sinus congestion and pressure
- minor aches and pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- cough due to minor throat and bronchial irritation
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
NIGHTTIME
-
temporarily relieves these common cold/flu symptoms
- nasal congestion
- sore throat
- headache
- sinus congestion and pressure
- minor aches and pains
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
- temporarily reduces
- fever
- cough to help you sleep
- swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- temporarily relieves common cold and flu symptoms
-
Warnings
DAYTIME
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
- child takes more than 4 doses (15 mL each) in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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.
NIGHTTIME
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- 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
DAYTIME NIGHTTIME
- 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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if you have
DAYTIME
- liver disease
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
NIGHTTIME
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- glaucoma
- a sodium-restricted diet
- 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
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
DAYTIME
taking the blood thinning drug warfarin.
NIGHTTIME
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
DAYTIME
do not take more than directed
NIGHTTIME
- do not take 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
DAYTIME
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult)
- 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.
NIGHTTIME
- nervousness, dizziness, or sleeplessness occur
- pain or 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.
Keep out of reach of children.
DAYTIME NIGHTTIME
Overdose warning:Taking more than the recommended dose (overdose) may couse liver damage. In case of overdose, get medical help or contact a Poison Control Center(1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
-
Directions
DAYTIME
- take only as directed (see Overdose warning)
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL= milliliter
adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use -
when using other Daytime or Night time products, carefully read each label to ensure correct dosing
NIGHTTIME
- take only as directed (see Overdose warning)
- Do not exceed 4 doses per 24
- measure only with dosing cup provided. Do not use any other dosing device.
- mL= milliliter
- keep dosing cup with product
- adults and children 12 years and over: 30 mL every 4 hours
- children under 12 years of age: do not use
- when using other Daytime or Nighttime products, carefully read each label or ensure correct dosing
- Other information
-
Inactive ingredients
Day Time
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride,sodium citrate, sorbitol, sucralose, xantham gum
Night Time
anhydrous citric acid, FD&C blue #1, Fd&C red #40, flavor, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, trisodium citrate dehydrate, sorbitol, sucralose, xanthan gum
- Questions or comments?
-
Principal Display Panel
when using daytime and nighttime products, carefully read the labeling to ensure correct dosing.
Compare to the active ingredients in VICKS® DAYQUIL® and NYQUIL® Severe Cold & Flu*
DAYTIME
Severe
day time cold & flu relief
Acetaminophen 325 mg Pain Reliever / Fever Reducer
Dextromethorphan HBr 10 mg Cough Suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCI 5 mg Nasal Decongestant
relieves:
- headache, fever, sore throat, minor aches & pains
- nasal/sinus congestion & sinus pressure
- Cough
- Chest congestion
For ages 6 years and over
max strength
non-drowsy
alcohol free
NIGHTTIME
maximum strength
severe
night time cold & flu relief
Acetaminophen 650 mg Pain Reliever / Fever Reducer
Dextromethorphan HBr 20 mg Cough Suppressant
Doxylamine Succinate 12.5 mg Antihistamine
Phenylephrine HCI 10 mg Nasal Decongestant
relieves:
- ache, fever, sore throat,
- cough
- Runny nose & sneezing
- nasal & sinus congestion
alcohol free
FL OZ (mL)
berry Flavor
*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil® 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
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF
acetaminophen dextromethorphan hbr guaifenesin phenylephrine hci doxylaminesucinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0813 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0813-6 1 in 1 KIT; Type 0: Not a Combination Product 03/26/2021 03/28/2025 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 237 mL Part 2 1 BOTTLE 237 mL Part 1 of 2 SEVERE COLD AND FLU RELIEF DAYTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Item Code (Source) NDC:49580-0415 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) GLYCERIN (UNII: PDC6A3C0OX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 237 mL 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 final part341 03/26/2021 03/28/2025 Part 2 of 2 SEVERE COLD AND FLU NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquidProduct Information Item Code (Source) NDC:49580-4160 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) GLYCERIN (UNII: PDC6A3C0OX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SACCHARIN SODIUM (UNII: SB8ZUX40TY) 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 1 237 mL 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 final part341 03/26/2021 02/28/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/26/2021 03/28/2025 Labeler - P & L Development, LLC (101896231)
