Label: COLD AND FLU SEVERE DAYTIME- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 36800-986-24
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated March 5, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- minor aches & pains
- sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 softgels 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
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
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
- high blood pressure
- thyroid disease
- trouble urinating due to enlarged prostate gland
- a sodium-restricted diet
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin; taking sedatives or tranquilizers.
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- 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 rash or headache that lasts.
These could be signs of a serious condition.
- Other information
- Inactive ingredients
PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton
*Compare to the active ingredients
in Vicks® Dayquil™ Severe Cold & Flu
Cold & Flu Relief
PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
EXPECTORANT - GUAIFENESIN
NASAL DECONGESTANT - PHENYLEPHRINE HCl
• Headache, Fever, Sore Throat, Minor Aches & Pains
• Sinus Congestion & Pressure
• Nasal Congestion • Cough
INGREDIENTS AND APPEARANCE
COLD AND FLU SEVERE DAYTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-986 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C Yellow no. 6 (UNII: H77VEI93A8) Gelatin, unspecified (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Polyethylene Glycol, unspecified (UNII: 3WJQ0SDW1A) Povidone K30 (UNII: U725QWY32X) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape OVAL Size 20mm Flavor Imprint Code 782 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-986-24 2 in 1 CARTON 05/01/2021 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 05/01/2021 Labeler - TOPCO ASSOCIATES LLC (006935977)