Label: DAYTIME NIGHTTIME COLD AND FLU RELIEF MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
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Contains inactivated NDC Code(s)
NDC Code(s): 68210-4150-1 - Packager: Spirit Pharmaceuticals 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 November 2, 2021
If you are a consumer or patient please visit this version.
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- Active ingredients in Daytime (in each softgel)
- Active ingredients in Nighttime (in each softgel)
- Purpose for Daytime
- Purpose for Nighttime
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Uses
DAYTIME
- temporarily relieves common cold and flu symptoms
- cough due to minor throat and bronchial irritation
- nasal congestion
- headache
- minor aches and pains
- fever
- sore throat
NIGHTTIME
- temporarily relieves common cold and fly symptoms
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pain
- fever
- runny nose and sneezing
- temporarily relieves common cold and flu symptoms
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Warnings
DAYTIME and NIGHTTIME
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses 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 and 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 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
DAYTIME
- liver disease
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
NIGHTTIME
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts such as occur with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
DAYTIME
- taking the blood thinning drug warfarin
NIGHTTIME
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product,
DAYTIME
do not exceed recommended dosage.
NIGHTTIME
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
DAYTIME
- nervousness, dizziness or sleeplessness occur
- pain, cough, and nasal congestion 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.
NIGHTTIME
- pain 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 and NIGHTTIME
Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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
DAYTIME
- do not take more than directed (see Overdose warning )
- do not take more than 4 doses in 24 hours
- adults and children 12 years and over: take 2 softgels with water every 4 hours
- children 4 to under 12 years of age: ask a doctor
- children under 4 years of age : do not use
Nighttime:
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in 24 hours
- adults and children 12 years and over: take 2 softgels with water every 6 hours
- children 4 to under 12 years of age: ask a doctor
- children under 4 years of age : do not use
- Other information
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Inactive ingredients
Daytime FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
Nighttime D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
Combo Pack
Non-drowsy daytimeCold & Flu
Acetaminophen -
Pain Reliever / Fever Reducer
Dextromethorphan HBr -
Cough Suppressant
Phenylephrine HCl - Nasal Decongestant
Relief of:
• Headache • Fever • Sore Throat
• Minor Aches & Pains • Nasal Congestion
• Sinus Pressure • Cough
6 SoftgelsNighttime
Cold & Flu
Acetaminophen -
Pain Reliever / Fever Reducer
Dextromethorphan HBr -
Cough Suppressant
Doxylamine Succinate - Antihistamine
Relief of:
• Headache • Fever • Sore Throat
• Minor Aches & Pains • Sneezing
• Runny Nose • Cough6 Softgels
Multi-symptom
12 Softgels
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INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD AND FLU RELIEF MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4150 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4150-1 1 in 1 CARTON; Type 0: Not a Combination Product 04/28/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 6 Part 2 1 BLISTER PACK 6 Part 1 of 2 NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsuleProduct Information 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 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION (UNII: 8KW3E207O2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape CAPSULE (OBLONG) Size 20mm Flavor Imprint Code 215;902 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 6 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 04/28/2021 Part 2 of 2 DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsuleProduct Information 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION (UNII: 8KW3E207O2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red (ORANGE TO RED) Score no score Shape CAPSULE (OBLONG) Size 20mm Flavor Imprint Code 512;A09 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 6 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 03/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/28/2021 Labeler - Spirit Pharmaceuticals LLC (179621011)