Daytime and Nighttime Cold and Flu Maximum Strength: Package Insert and Label Information

DAYTIME AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hcl / acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
Walgreens

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 FACTS — Nighttime Cold & Flu

Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses
• temporarily relieves these common cold and flu symptoms:
sinus congestion and pressure
cough
minor aches and pains
headache
nasal congestion
sore throat
runny nose
sneezing
itching of the nose or throat

itchy, watery eyes due to hay fever
• controls cough to help you get to sleep
• 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
• 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
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• trouble urinating due to enlarged prostate gland
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occur
• 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 fever, 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 older: 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 #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

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

DRUG FACTS — Daytime Cold & Flu

Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purposes
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses
• temporarily relieves common cold and flu symptoms:
sinus congestion and pressure
cough
minor aches and pains
headache
nasal congestion
sore throat
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• controls cough to help you get to sleep
• 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
• 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
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• trouble urinating due to enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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
• nervousness, dizziness, or sleeplessness occur
• 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 fever, 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 older: 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 yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

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

PRINCIPAL DISPLAY PANEL

630T-Walgreens-MaxStrength-coldflu-ifc-24s
(click image for full-size original)

DAYTIME AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hcl / acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0775
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0775-24 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (0363-0775-24)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 BLISTER PACK 16
Part 2 1 BLISTER PACK 8
Part 1 of 2
DAYTIME COLD AND FLU MAXIMUM STRENGTH acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hcl capsule, liquid filled
Product Information
Item Code (Source) NDC:0363-0750
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
POVIDONE K30
PROPYLENE GLYCOL
WATER
SORBITOL
SORBITAN
TITANIUM DIOXIDE
Product Characteristics
Color orange Score no score
Shape OVAL (OBLONG) Size 21mm
Flavor Imprint Code 78
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/01/2022
Part 2 of 2
NIGHTTIME COLD AND FLU MAXIMUM STRENGTH acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled
Product Information
Item Code (Source) NDC:0363-1011
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
POVIDONE K30
PROPYLENE GLYCOL
WATER
SORBITOL
SORBITAN
SODIUM HYDROXIDE
TITANIUM DIOXIDE
Product Characteristics
Color green Score no score
Shape OVAL (OBLONG) Size 21mm
Flavor Imprint Code 72
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/01/2022
Labeler — Walgreens (008965063)
Registrant — TIME CAP LABORATORIES INC (037052099)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LTD 925822975 manufacture (0363-0775)

Revised: 06/2022 Walgreens

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