DELSYM COUGH PLUS COLD DAY TIME- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride powder, for solution

Delsym by

Drug Labeling and Warnings

Delsym by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each packet)	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:

• nasal congestion
• cough
• minor aches and pains
• sore throat
• headache
• temporarily reduces fever
• sinus congestion and pressure
• temporarily 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

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 packets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily 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

• 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
• diabetes
• high blood pressure
• thyroid disease
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• 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 fever, rash, or headache that lasts. These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Directions

• do not take more than directed (see Overdose warning)
• do not take more than 6 packets in any 24-hour period
• adults and children 12 years of age and older: 1 packet every 4 hours
• Dissolve contents of one packet into 8 oz of hot water and stir; sip while hot. Consume within 15 minutes.
• children under 12 years of age: do not use

Other information

• each packet contains: sodium 130 mg
• phenylketonurics: contains phenylalanine 41 mg per packet
• store between 20-25°C (68-77°F)
• protect from excessive heat and moisture

Inactive ingredients

anhydrous citric acid, aspartame, D&C Yellow #10, FD&C Red #40, flavors, saccharin sodium, sucrose, trisodium citrate dihydrate

Questions?

1-888-963-3382

You may also report side effects to this phone number.

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Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England

PRINCIPAL DISPLAY PANEL - 8 Packet Carton

NDC: 63824-112-08

NEW!

MAX Strength*

Delsym®

COUGH +™ COLD

DAY TIME

Acetaminophen (Pain Reliever/Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
Phenylephrine HCl (Nasal Decongestant)

✓ Cough
✓ Sore Throat
✓ Fever
✓ Headache
✓ Nasal & Chest
Congestion

HONEY LEMON
Flavored Mix

For Ages 12+

8 Packets

INGREDIENTS AND APPEARANCE

DELSYM   COUGH PLUS COLD DAY TIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-112
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
guaifenesin (UNII: 495W7451VQ) (guaifenesin - UNII:495W7451VQ)	guaifenesin	400 mg
phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV)	phenylephrine hydrochloride	10 mg

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
aspartame (UNII: Z0H242BBR1)
D&C Yellow No. 10 (UNII: 35SW5USQ3G)
FD&C Red No. 40 (UNII: WZB9127XOA)
saccharin sodium (UNII: SB8ZUX40TY)
sucrose (UNII: C151H8M554)
trisodium citrate dihydrate (UNII: B22547B95K)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-112-08	8 in 1 CARTON; Type 0: Not a Combination Product	04/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/01/2014

Labeler - RB Health (US) LLC (081049410)