Label: COLD AND FLU SEVERE- acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl solution
- NDC Code(s): 0363-8078-45
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 21, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purpose
-
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- sore throat
- minor aches and pains
- cough
- sinus congestion and pressure
- sneezing
- itching of the nose or throat
- runny nose
- itchy, watery eyes due to hay fever
- headache
- 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 4,000 mg of acetaminophen in 24 hours
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- diabetes
- cough that occurs with too much phlegm (mucus)
- heart disease
- liver disease
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- thyroid disease
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution 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
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
NDC 0363-8078-45
Walgreens
• WALGREENS •
PHARMACIST RECOMMENDED†
Compare to the active ingredients in
Maximum Strength Mucinex®
NIGHTSHIFT® Severe Cold & Flu††NIGHTTIME
Severe
Cold & Flu
ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT
TRIPROLIDINE HCl / ANTIHISTAMINEMaximum Strength
• Relieves headache, body pain,
sore throat, fever, itchy throat,
cough, nasal congestion,
runny nose & sneezing
• 12 years & older6 FL OZ (177 mL)
†Our pharmacists
recommend the
Walgreens brand.
We invite you to
compare to national brands.
††This product is not manufactured or
distributed by RB Health (US) LLC, owner of the
registered trademark Maximum Strength
Mucinex® NIGHTSHIFT® Severe Cold & Flu.
DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2023 Walgreen Co.PARENTS:
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www.StopMedicineAbuse.orgTAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Walgreens 44-078
-
INGREDIENTS AND APPEARANCE
COLD AND FLU SEVERE
acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-8078 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 2.5 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color blue Score Shape Size Flavor FRUIT (MIXED) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-8078-45 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/21/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/21/2023 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 manufacture(0363-8078) , pack(0363-8078)