DayQuil Severe plus Vicks VapoCool Cold and Flu — v16

DayQuil Severe plus Vicks VapoCool Cold and Flu

6 Views

Version

v16

Effective date

October 1, 2025

Original packager

Yes

Sections captured

20

Identifiers

Document ID
401e3846-65ef-b4e8-e063-6294a90ac30a
Set ID
724f2833-34bd-6a9e-e053-2991aa0a073d
Application numbers
M012
Product NDCs
37000-524
Package NDCs
37000-524-02
Original packager NDCs

Names & Manufacturers

Brand names
DayQuil Severe plus Vicks VapoCool Cold and Flu
Generic names
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE
Manufacturer names
The Procter & Gamble Manufacturing Company
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Routes
ORAL
Pharmacologic class (PE)
Decreased Respiratory Secretion Viscosity [PE], Increased Respiratory Secretions [PE]
Pharmacologic class (EPC)
Expectorant [EPC]
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
N0000008867, N0000009560, N0000193956
RxCUI
1110988
UNII
04JA59TNSJ, 362O9ITL9D, 495W7451VQ, 9D2RTI9KYH
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 Guaifenesin 200 mg Phenylephrine HCl Purpose Pain reliever/Fever reducer Cough suppressant Expectorant Nasal decongestant
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Do Not Use (1)

Sequence 1

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.
Dosage And Administration (1)

Sequence 1

Directions take only as directed do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Dosage And Administration Table (1)

Sequence 1

adults & children 12 yrs & over2 caplets with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
Inactive Ingredient (1)

Sequence 1

Inactive ingredients croscarmellose sodium, crospovidone, FD&C Yellow No. 6 Aluminum Lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Indications And Usage (1)

Sequence 1

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children.
Overdosage (1)

Sequence 1

Overdose warning 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.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch DayQuil ™ SEVERE + VICKS ® Vapo COOL ™ COLD & FLU Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin Minor Aches & Pains, Fever Nasal Congestion & Sinus Pressure Cough Chest Congestion Non-Drowsy 2 COATED CAPLETS 2CT
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding , ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Pain reliever/Fever reducer Cough suppressant Expectorant Nasal decongestant
Questions (1)

Sequence 1

Questions? 1-800-362-1683
Spl Product Data Elements (1)

Sequence 1

DayQuil Severe plus Vicks VapoCool Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride SUCRALOSE STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C YELLOW NO. 6 ALUMINUM OXIDE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL POVIDONE SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DQ
Spl Unclassified Section (3)

Sequence 1

Drug Facts

Sequence 2

TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

Sequence 3

DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202
Stop Use (1)

Sequence 1

Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, 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.
Storage And Handling (1)

Sequence 1

Other information each caplet contains: sodium 4 mg do not exceed 25°C
Warnings (1)

Sequence 1

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hrs, which is the maximum daily amount for this product 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 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 liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, 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. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning 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.
When Using (1)

Sequence 1

When using this product, do not use more than directed.

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['DayQuil Severe plus Vicks VapoCool Cold and Flu'],
 'generic_name': ['ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, '
                  'AND PHENYLEPHRINE HYDROCHLORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['The Procter & Gamble Manufacturing Company'],
 'nui': ['N0000193956', 'N0000008867', 'N0000009560'],
 'package_ndc': ['37000-524-02'],
 'pharm_class_epc': ['Expectorant [EPC]'],
 'pharm_class_pe': ['Decreased Respiratory Secretion Viscosity [PE]',
                    'Increased Respiratory Secretions [PE]'],
 'product_ndc': ['37000-524'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['1110988'],
 'spl_id': ['401e3846-65ef-b4e8-e063-6294a90ac30a'],
 'spl_set_id': ['724f2833-34bd-6a9e-e053-2991aa0a073d'],
 'substance_name': ['ACETAMINOPHEN',
                    'DEXTROMETHORPHAN HYDROBROMIDE',
                    'GUAIFENESIN',
                    'PHENYLEPHRINE HYDROCHLORIDE'],
 'unii': ['362O9ITL9D', '9D2RTI9KYH', '495W7451VQ', '04JA59TNSJ']}