UP AND UP  NIGHTTIME FLU AND SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution 
Target Corporation

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.

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up & up
nighttime flu and severe cold and cough

Drug Facts

Active ingredients (in each packet)Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Diphenhydramine hydrochloride 25 mgAntihistamine/cough suppressant
Phenylephrine hydrochloride 10 mgNasal decongestant

Uses

Warnings

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.

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

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 4 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 pharmacist.
  • with any other product containing diphenhydramine, even one used on the skin
  • 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
  • diabetes
  • glaucoma
  • a sodium-restricted diet
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema, asthma or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are taking

  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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
  • symptoms do not get better or worsen
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a heath care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

AgeDose
children under 4 years of agedo not use
children 4 to under 12 years of agedo not use unless directed by a doctor
adults and children 12 years of age and overone packet

Other information

Inactive ingredients

acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.

Questions or Comments?

Call 1-800-910-6874

Distributed by Target Corporation
Minneapolis, MN 55403

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

See new warnings information & directions

NDC 11673-113-07

Compare to active ingredients in
Theraflu® Nighttime Severe Cold & Cough*

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acetaminophen (pain reliever/fever reducer)
diphenhydramine HCl (antihistamine/cough suppressant)
phenylephrine HCl (nasal decongestant)

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runny nose, sneezing,
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6
PACKETS

6 PACKETS

PRINCIPAL DISPLAY PANEL - 6 Packet Carton
UP AND UP   NIGHTTIME FLU AND SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-113
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg
Diphenhydramine hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine hydrochloride25 mg
Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium (UNII: 23OV73Q5G9)  
aspartame (UNII: Z0H242BBR1)  
anhydrous citric acid (UNII: XF417D3PSL)  
D&C yellow no. 10 (UNII: 35SW5USQ3G)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
FD&C red no. 40 (UNII: WZB9127XOA)  
maltodextrin (UNII: 7CVR7L4A2D)  
anhydrous trisodium citrate (UNII: RS7A450LGA)  
sucrose (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-113-076 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/28/2013
Labeler - Target Corporation (006961700)

Revised: 4/2015
Document Id: 8e7a26af-db1f-4441-b58c-aebd1324637c
Set id: df488727-b913-440b-9a0b-cce3ae143bf2
Version: 2
Effective Time: 20150423
 
Target Corporation