Label: SEVERE COLD AND COUGH DAYTIME- acetaminophen, dextromethorphan, phenylephrine powder, for solution
- NDC Code(s): 67091-322-06
- Packager: WinCo Foods, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each packet)
- Purposes
- Uses
-
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
- ▪
- in a child under 12 years of age
- ▪
- if you are allergic to acetaminophen
- ▪
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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 doctor before use if you have
- ▪
- liver disease
- ▪
- heart disease
- ▪
- high blood pressure
- ▪
- thyroid disease
- ▪
- diabetes
- ▪
- 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
Stop use and ask a doctor if
- ▪
- nervousness, dizziness, or sleeplessness occurs
- ▪
- 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 rash or headache that lasts. These could be signs of a serious condition.
-
Directions
- ▪
- do not use more than directed
- ▪
- take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
Age
Dose
adults and children 12 years of age and over
one packet
children under 12 years of age
do not use
- ▪
- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- ▪
- 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
- Inactive ingredients
- Questions or comments?
-
Principal Display
*Compare to the active ingredients in THERAFLU® Daytime Severe Cold &Cold
WinCo FOODS
Severe Cold & Cough
Daytime
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
- •
- Relieves: Nasal Congestion, Sore Throat Pain, Cough, Headache, Body Ache & Fever
6 PACKETS
Berry Infused with Menthol & Green Tea Flavors
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED PACKET IS TORN OR BROKEN
The Supermarket Low price Leader ®
100% SATISFACTION GUARANTEE
Comments & Questions?
800-824-1706 www.wincofoods.com
DISTRIBUTED BY:
WINCO FOODS, LLC,
BOISE, ID 83704
*This product is not manufactured or distributed by GSK consumer Healthcare, owner of the registered trademark THERAFLU® Daytime Severe Cold & Cough.
-
INGREDIENTS AND APPEARANCE
SEVERE COLD AND COUGH DAYTIME
acetaminophen, dextromethorphan, phenylephrine powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-322 Route of Administration ORAL 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Product Characteristics Color Score Shape Size Flavor BERRY (Infused with Menthol & Green Tea) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-322-06 6 in 1 CARTON 08/01/2018 1 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/01/2018 Labeler - WinCo Foods, LLC (056098817)
