CVS Pharmacy TIME CAP LABORATORIES, INC. MARKSANS PHARMA LIMITED

Daytime Cold and Flu and Nighttime Softgels Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate Daytime Cold and Flu Acetaminophen, Dextromethorphan HBr SORBITOL SOLUTION GELATIN, UNSPECIFIED SHELLAC POVIDONE, UNSPECIFIED WATER DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GLYCERIN SORBITAN FD&C RED NO. 40 PROPYLENE GLYCOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN FD&C YELLOW NO. 6 199 OBLONG SHAPED CAPSULE Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate POLYETHYLENE GLYCOL, UNSPECIFIED DOXYLAMINE SUCCINATE DOXYLAMINE GLYCERIN D&C YELLOW NO. 10 FD&C BLUE NO. 1 PROPYLENE GLYCOL WATER POVIDONE, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN SHELLAC GELATIN, UNSPECIFIED SORBITAN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN TITANIUM DIOXIDE SORBITOL SOLUTION 191 OBLONG SHAPED CAPSULE

Drug Facts

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

Purposes Pain reliever/fever reducer Cough suppressant

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 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.

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 persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

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 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.

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

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.

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

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

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

Drug Facts

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

Purposes Pain reliever/fever reducer Cough suppressant Antihistamine

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 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.

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 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)

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

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

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.

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

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.

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

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

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

CVS 907T 24ct CVS 907T 24ct