Label: DAYQUIL SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
- Packager: Lil' Drug Store Products, Inc
- 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 23, 2017
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
- 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 4 doses in 24 hrs, 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
Allergy Alert: 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
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- take only as directed
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
- Other information
- each caplet contains: sodium 4 mg
- store at room temperature
- Inactive ingredients
croscarmellose sodium, crospovidone, FD&C Yellow No. 6, maltodextrin, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxideClose
- PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton
COLD & FLU
Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin
- Headache, Fever, Sore Throat, Minor Aches & Pains
- Nasal/Sinus Congestion & Sinus Pressure
- Chest Congestion
- INGREDIENTS AND APPEARANCE
DAYQUIL SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9704 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 Croscarmellose Sodium (UNII: M28OL1HH48) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) FD&C yellow no. 6 (UNII: H77VEI93A8) Maltodextrin (UNII: 7CVR7L4A2D) Microcrystalline Cellulose (UNII: OP1R32D61U) Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A) Polysorbate 80 (UNII: 6OZP39ZG8H) Polyvinyl Alcohol, Unspecified (UNII: 532B59J990) Povidone, Unspecified (UNII: FZ989GH94E) Silicon Dioxide (UNII: ETJ7Z6XBU4) Stearic Acid (UNII: 4ELV7Z65AP) Talc (UNII: 7SEV7J4R1U) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape OVAL Size 19mm Flavor Imprint Code DQ Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9704-8 4 in 1 CARTON 06/21/2013 11/21/2014 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:66715-9704-3 3 in 1 CARTON 06/21/2013 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:66715-9704-2 2 in 1 CARTON 06/21/2013 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:66715-9704-1 1 in 1 CARTON 06/21/2013 11/11/2015 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:66715-9704-7 20 in 1 CARTON 06/21/2013 5 2 in 1 POUCH; 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 06/21/2013 Labeler - Lil' Drug Store Products, Inc (093103646)