Label: WAL FLU SEVERE COLD AND COUGH DAYTIME- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride powder, for solution
- NDC Code(s): 0363-0096-91
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each packet)
Acetaminophen 650 mg
Dextromethorphan hydrobromide 20 mg
Phenylephrine hydrochloride 10 mgClose
Pain reliever/fever reducer
- temporarily relieves
- minor aches and pains
- minor sore throat
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 packets in 24 hours, 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
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
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a sodium-restricted diet
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with fever, rash or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children.
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.
- do not use more than directed – see Liver warning
- take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
- adults and children 12 years of age and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- children under 12 years of age: consult a doctor
- if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
- Other information
- each packet contains: potassium 5 mg and sodium 41 mg
- phenylketonurics: contains phenylalanine 17 mg per packet
- store at 20º-25ºC (68º-77ºF)
- Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphateClose
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- Package/Label Principal Display Panel
Compare to Theraflu® Severe Cold & Cough active ingredients
See New Warnings Information
Severe Cold & Cough
Pain Reliever–Fever Reducer (Acetaminophen)
Cough Suppressant (Dextromethorphan HBr)
Nasal Decongestant (Phenylephrine HCl)
Nasal & Sinus Congestion
Sore Throat Pain
Berry Infused with Menthol & Green Tea Flavors
Wal-Flu(R) Severe Cold and Cough Carton
- INGREDIENTS AND APPEARANCE
WAL FLU SEVERE COLD AND COUGH DAYTIME
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0096 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0096-91 6 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/17/2012 Labeler - Walgreen Company (008965063)