Medicine guide

Signature Care Nighttime Severe Cold and Flu Relief

650 mg/30mL + 20 mg/30mL + 12.5 mg/30mL + 10 mg/30mL · Solution

Available without prescription
Antihistamine

Active substance: Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Used in: Breathing, airways, allergies and cough
Made by: Safeway
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-10-30

What it is

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Used for

Sinus congestion and pressure
Nasal congestion
Minor aches and pains
Headache
Runny nose and sneezing

+7 more

How to take it

Adults & children 12 yrs & over 30 mL every 4 hrs

Full directions ↓

Do not take it if

With any other drug containing acetaminophen (prescription or nonprescription).

All warnings ↓

Good to know

Sold without a prescription
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

75other products contain Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

temporarily relieves common cold/flu symptoms:

sinus congestion and pressure
nasal congestion
minor aches and pains
headache
runny nose and sneezing
sore throat
cough to help you sleep
fever
cough due to minor throat and bronchial irritation
reduces swelling of nasal passages
promotes nasal and/or sinus drainage
temporarily restores freer breathing through the nose

From the official label · 2024-10-30 · DailyMed

Do not take it if

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.
if you have ever had an allergic reaction to this product or any of its ingredients

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

These directions are for this exact strength and form. Another one is different.

take only as directed – see Overdose warning
only use the dose cup provided
do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 30 mL every 4 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use

Quoted from the official label, section “Dosage & Administration”.

Ask a doctor first if

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

Quoted from the official label, section “OTC — Ask Doctor”.

Ask a pharmacist first if

you are
taking sedatives or tranquilizers
taking the blood thinning drug warfarin

Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.

Stop and get help 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.

Quoted from the official label, section “OTC — Stop Use”.

Other warnings

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 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. 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
Ask a doctor before use
if you have
diabetes
glaucoma
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
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and
ask a doctor if
cough comes back or occurs with 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:
do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Keep away from children

Overdose warning:
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for
adults as well as for children even
if you do not notice any signs or symptoms.

Quoted from the official label, section “OTC — Keep Out of Reach of Children”.

How to store it

each 30 mL contains: sodium 41 mg
store at 20-25°C (68-77°F)

Quoted from the official label, section “Storage and Handling”.

What kind of medicine it is

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Quoted from the official label, section “Inactive Ingredients”.

Questions about this product

1-800-719-9260

Quoted from the official label, section “OTC — Questions”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Colour dyesFD&C blue #1; FD&C red #40Some people react to dyes such as tartrazine (Yellow 5) or carmine.
Sugar alcoholssorbitol solutionSorbitol and similar can upset the stomach and matter with fructose intolerance.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (22)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 22 of 22

Details

Made by	Safeway
Active substance	Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Used in	Breathing, airways, allergies and cough
Strength	650 mg/30mL + 20 mg/30mL + 12.5 mg/30mL + 10 mg/30mL
Form	Solution
Route	Oral
Packs	355 mL in 1 BOTTLE
NDC	21130-129

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

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