Label: QUALITY CHOICE SEVERE COLD AND COUGH NIGHTTIME- acetaminophen, diphenhydramine, phenylephrine powder, for solution
- NDC Code(s): 63868-291-06
- Packager: Chain Drug Manufacturing Assn
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 8, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each packet)
- Purposes
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Uses
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- temporarily relieves these symptoms due to a cold:
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- minor aches and pains
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- minor sore throat pain
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- headache
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- nasal and sinus congestion
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- runny nose
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- sneezing
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- itchy nose or throat
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- itchy, watery eyes due to hay fever
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- cough due to minor throat and bronchial irritation
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- temporarily reduces fever
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions, Symptoms may include:
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- skin reddening
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- blisters
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- 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.
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Do not use
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- in a child under 12 years of age
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- if you are allergic to acetaminophen
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- 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.
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- with any other product containing diphenhydramine, even one used on the skin
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- 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 a MAOI, ask a doctor or pharmacist before taking this product.
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Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema, asthma or chronic bronchitis
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- Ask a doctor or pharmacist before use if you are
- When using this product
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Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occurs
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- symptoms do not get better or worsen
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- pain, cough or nasal congestion gets worse or lasts more than 7 days
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- cough comes back or occurs with fever, rash or headache that lasts. There could be signs of a serious condition.
- If pregnant or breast- feeding,
- Keep out of reach of children.
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Directions
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- do not use more than directed
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- take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor
Age
Dose
children under 12 years of age
do not use unless directed by a doctor
adults and children 12 years of age and over
one packet
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- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
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- 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?
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Additional Information Listed On Other Panels
QC Quality Choice
*Compare to the Active Ingredients in Theraflu® Nighttime Severe Cold &Cough
Severe Cold & Cough
Nighttime
Acetaminophen - Pain Reliever/ Fever Reducer
Diphenhydramine HCl - Antihistamine/ Cough Suppressant
Phenylephrine HCl - Nasal Decongestant
Aspartame Free● Sodium Free
- Relieves :
- Nasal Congestion ǀ Cough ǀ Runny Nose ǀ Sneezing ǀ Body Ache ǀ Sore Throat Pain ǀ Headache ǀ Fever.
Honey Lemon Infused with Chamomile and White Tea Flavors
6 Packets
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.
Distributed by: C.D.M.A., Inc ©
43157 W. 9 Mile Rd
Novi, MI 48375
Questions: 248-449-9300
*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Theraflu® Nighttime Severe Cold & Cough.
- Principal Display
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE SEVERE COLD AND COUGH NIGHTTIME
acetaminophen, diphenhydramine, phenylephrine powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-291 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Product Characteristics Color Score Shape Size Flavor HONEY, LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-291-06 6 in 1 CARTON 07/16/2018 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 07/16/2018 Labeler - Chain Drug Manufacturing Assn (011920774)