CVS 907T Daytime Cold and Flu and Nighttime Softgels

Set ID
4981bbcd-7178-335f-e063-6394a90ae961
Manufacturer
CVS Pharmacy | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2026-03-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:50:18

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg

OTC - PURPOSE SECTION

Purposes Pain reliever/fever reducer Cough suppressant

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

OTC - ACTIVE INGREDIENT SECTION

Purposes Pain reliever/fever reducer Cough suppressant Antihistamine

Uses

INDICATIONS & USAGE SECTION

Uses temporarily relieves these common cold and flu symptoms: - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the intensity of coughing - the impulse to cough to help you get to sleep - minor aches and pains - sore throat - headache temporarily reduces fever

INDICATIONS & USAGE SECTION

Uses temporarily relieves these common cold and flu symptoms: - cough - minor aches and pains - sore throat - headache - runny nose - sneezing - itching of the nose or throat - itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep

Warnings

WARNINGS SECTION

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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.

OTC - DO NOT USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

WARNINGS SECTION

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed (see Overdose warning) do not take more than 12 softggels in any 24-hour period adults and children 12 years of age and over: take 2 softgels every 4 hours children under 12 years of age: do not use

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed (see Overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and over: take 2 softgels every 4 hours children under 12 years of age: do not use

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive ingredients FD&C blue no. 1, gelatin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

INACTIVE INGREDIENT SECTION

Inactive ingredients D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Products

NDC Codes

Ingredients

NameUNIIKind
SORBITOL SOLUTION8KW3E207O2IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
SHELLAC46N107B71OIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
WATER059QF0KO0RIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GLYCERINPDC6A3C0OXIACT
SORBITAN6O92ICV9RUIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
ACETAMINOPHEN362O9ITL9DACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
GLYCERINPDC6A3C0OXIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
ACETAMINOPHEN362O9ITL9DACTIB
SHELLAC46N107B71OIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
SORBITAN6O92ICV9RUIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
SORBITOL SOLUTION8KW3E207O2IACT

Complete SPL Sections

D​aytime Cold & Flu Softgels

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purposes Pain reliever/fever reducer Cough suppressant

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Uses temporarily relieves these common cold and flu symptoms: - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the intensity of coughing - the impulse to cough to help you get to sleep - minor aches and pains - sore throat - headache temporarily reduces fever

WARNINGS SECTION

WARNINGS SECTION

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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.

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

When using this product do not use more than directed

OTC - STOP USE SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed (see Overdose warning) do not take more than 12 softggels in any 24-hour period adults and children 12 years of age and over: take 2 softgels every 4 hours children under 12 years of age: do not use

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

Other information store at 20-25°C (68-77°F) avoid excessive heat

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients FD&C blue no. 1, gelatin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Nighttime Cold & Flu Softgels

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Purposes Pain reliever/fever reducer Cough suppressant Antihistamine

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Uses temporarily relieves these common cold and flu symptoms: - cough - minor aches and pains - sore throat - headache - runny nose - sneezing - itching of the nose or throat - itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep

WARNINGS SECTION

WARNINGS SECTION

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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.

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed (see Overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and over: take 2 softgels every 4 hours children under 12 years of age: do not use

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

Other information store at 20-25°C (68-77°F) avoid excessive heat

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS 907T 24ct

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc4d1f5695-0bcb-6a29-e063-6394a90ae92a.xml2026-03-17
otcCVS 907T 24ct.jpg2026-03-17
otc4981bbcd-7179-335f-e063-6394a90ae961.xml2026-02-06
otcCVS 907T.jpg2026-02-06