Label: DAYTIME SEVERE COLD AND COUGH AND NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kit
- NDC Code(s): 11673-540-06, 11673-541-06, 11673-542-12
- Packager: Target Corporation
- 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.
Drug Label Information
Updated January 18, 2018
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- Active ingredients (in each packet) – Daytime Severe Cold and Cough
- Active ingredients (in each packet) - Nighttime Severe Cold and Cough
- Purposes - Daytime Severe Cold and Cough
- Purpose - Nighttime Severe Cold and Cough
- Uses - Daytime Severe Cold and Cough
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Uses - Nighttime Severe Cold and Cough
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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 – Daytime Severe Cold and Cough and Nighttime Severe Cold and Cough
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:
●Skin reddening● blisters● rash
Is 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 - Daytime Severe Cold and Cough
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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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- 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.
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Do not use - Nighttime Severe Cold and Cough
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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 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.
- Ask a doctor before use if you have - Daytime Severe Cold and Cough
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Ask a doctor before use if you have - Nighttime Severe Cold and Cough
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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 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 - Daytime Severe Cold and Cough
- Ask a doctor or pharmacist before use if you are - Nighttime Severe Cold and Cough
- When using this product - Daytime Severe Cold and Cough
- When using this product - Nighttime Severe Cold and Cough
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Stop use and ask a doctor if – Daytime Severe Cold and Cough /Nighttime Severe Cold and Cough
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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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- pain, cough or nasal congestion gets worse or lasts more than 7 days
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions – Daytime Severe Cold and Cough
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- do not use more than directed
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- 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
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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
Directions Nighttime Severe Cold and Cough
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- do not use more than directed
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- 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
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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 - Daytime Severe Cold and Cough
- Other information - Nighttime Severe Cold and Cough
- Inactive ingredients - Daytime Severe Cold and Cough
- Inactive ingredients - Nighttime Severe Cold and Cough
- Questions or comments?
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Package/Label Principal Display Panel
Compare to active ingredients in Theraflu® Daytime Severe Cold and Cough and Nighttime Severe Cold & Cough*
Value pack
daytime severe cold and cough
acetaminophen(pain reliever/ fever reducer)
dextromethorphan HBr ( cough suppressant)
phenylephrine HCl ( nasal decongestant)
aspartame free, sodium free
relief of nasal and sinus congestion,, cough ,body ache, sore throat pain, headache ,fever
berry flavor
infused with menthol and green tea flavors
6 PACKETS
nighttime severe cold and cough
acetaminophen –(pain reliever/ fever reducer)
diphenhydramine HCl – (antihistamine/ cough suppressant)
phenylephrine HCl – (nasal decongestant)
aspartame free, sodium free
relief of nasal congestion,, cough ,runny nose, sneezing, body ache, sore throat pain, headache ,fever
honey lemon flavor infused with chamomile & white tea flavors
6 PACKETS
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD.
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 –HOUR PERIOD.
DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR.
*These Products are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Daytime Severe Cold & Cough and Theraflu Nighttime severe Cold & Cough
Distributed by: Target Corporation.
Minneapolis, MN 55403
TM &©2017 Target Brands, Inc.
Tamper Evident Inner Unit
Do not use if sealed packet is Torn or Broken
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INGREDIENTS AND APPEARANCE
DAYTIME SEVERE COLD AND COUGH AND NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-542 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-542-12 1 in 1 CARTON; Type 0: Not a Combination Product 07/31/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CARTON 6 Part 2 1 CARTON 6 Part 1 of 2 DAYTIME SEVERE COLD AND COUGH
acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solutionProduct Information Item Code (Source) NDC:11673-540 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CHLORIDE (UNII: 660YQ98I10) FD&C RED NO. 40 (UNII: WZB9127XOA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-540-06 6 in 1 CARTON; 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 07/31/2017 Part 2 of 2 NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solutionProduct Information Item Code (Source) NDC:11673-541 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) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-541-06 6 in 1 CARTON; 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 07/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/31/2017 Labeler - Target Corporation (006961700)
