COLD AND FLU DAYTIME, NIGHTTIME, MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl 
Spirit Pharmaceuticals LLC

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.

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Non-Drowsy Daytime & Nighttime Cold and Flu

Active ingredients (in each liquid-filled capsule) (Daytime Cold & Flu)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Active ingredients (in each liquid-filled capsule) (Nighttime Cold & Flu)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • to make a child sleepy (Nighttime only)

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease (Daytime only)
  • diabetes (Daytime only)
  • thyroid disease (Daytime only)
  • high blood pressure (Daytime only)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
  • glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur (Daytime only)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
  • pain or cough gets worse or lasts more than 7 days  (Nighttime only)
  • 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

Directions (Daytime only)

Directions (Nighttime only)

Other information

Inactive ingredients (Daytime only)

FD&C Yellow No. 6, FD&C Red No. 40, gelatin, glycerin, polyethylene
glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan,
titanium dioxide

Inactive ingredients (Nighttime only)

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene
glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan,
titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Compare to Vicks® DayQuil® &
NyQuil® Cold & Flu LiquiCaps®
active ingredients†

DAYTIME • NON DROWSY
Cold & Flu

ACETAMINOPHEN /
PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT
PHENYLEPHRINE HCl /
NASAL DECONGESTANT

MULTI-SYMPTOM

ACTUAL
SIZE

32
LIQUID
CAPS

NIGHTTIME
Cold & Flu

ACETAMINOPHEN /
PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE /
ANTIHISTAMINE

MULTI-SYMPTOM

ACTUAL
SIZE

16

LIQUID
CAPS

48 TOTAL LIQUID CAPS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED


OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY
SIGNS OF TAMPERING

Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey

††This product is not manufactured or
distributed by Procter & Gamble, owner of the
registered trademark Vicks® DayQuil® &
NyQuil® Cold & Flu LiquiCaps®.

image description

COLD AND FLU  DAYTIME, NIGHTTIME, MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4111
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4111-11 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product09/16/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 BLISTER PACK 32 
Part 22 BLISTER PACK 16 
Part 1 of 2
COLD AND FLU   DAYTIME, MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
GELATIN (UNII: 2G86QN327L)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Colorred (ORANGE TO RED) Scoreno score
ShapeCAPSULE (Softgels) Size21mm
FlavorImprint Code 512
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/16/2020
Part 2 of 2
COLD AND FLU   NIGHTTIME, MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize21mm
FlavorImprint Code 215
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/16/2020
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 1/2022
Document Id: d57cb612-46ab-826e-e053-2995a90aab7f
Set id: 96c3965f-a1fe-4aa2-8580-f54083781aa1
Version: 2
Effective Time: 20220113
 
Spirit Pharmaceuticals LLC